AMS Solutions for Lifem

American Medical Systems 10700 Bren Road West Minnetonka, MN 55343 USA

URGENT Field Safety Notice

Phone: 1-952-930-6499 Fax: 1-952-931 -8490

AMS 800 Urinary Control System Control Pump Medical Device Recall

May 9,201 1

Account Name Address1 Address2 Address3 City, State Zip

American Medical Systems 10700 Bren Road West Minnetonka, MN 55343 USA

Dear <NAME>,

This letter is to inform that American Medical Systems (AMS) is recalling all unexpired AMS 80003 Control Pumps. This recall affects the following AMS 800 control Pumps:

of the Control Pump.

AMS 800TM Urinary Control System Control Pump with Inhibizonem REF 72404127

201 1 JUL-02

Lot Numbers Manufacturing Dates

Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activation of the control pump. Inadvertent activation of the control pump during the first eight weeks following implant could lead to urinary retention or, in a catheterized patient, could lead to tissue damage, erosion, and/or increase the risk of infection. AMS believes the likelihood of a serious adverse health consequence is remote, and does not recommend explanting Control Pumps at this time.

724041 27 I REFlPart #

We have consulted a panel of urologists who recommend that patients recently implanted with Control Pumps, who are within the eight week recovery period and have a deactivated device, should be followed per standard surgical procedure. Patients should also be reminded the importance of keeping their routine follow-up appointments during the eight week post-surgical period and be advised that should they experience symptoms of retention, to contact their urologist immediately. Control Pumps that have yet to be implanted should be returned to AMS immediately. AMS has sent a separate letter to physicians providing notification and instructions for the recall.

72400098 (non-Inhibizone)

331 544001 - 708953020 Jan. 01,2006 - Apr. 27,201 1

We encourage you to report any problem to AMS Complaint Reporting at: ~ - l Telephone: 1-952-930-6499, ext. 6525 Consumer Affairs IZ.l E-mail: Consumer.Affairs2@ammd.com

www~orkanMedic91Syste11~.com

(with Inhibizone) 517943001-707608020

Jan. 01,2009 - Apr. 27,201 1

Should you have any questions or require additional information, or to report a product problem please contact American Medical Systems at: c3 Telephone: 0800 0322 308 f3 Fax: 0800 0322 307 or 020 8995 3720 C;I Mail to: American Medical Systems

10700 Bren Road West Minnetonka, MN 55343

AMS asks that you return any existing stock of AMS 800 Control Pumps at our expense. Please contact AMS Customer Service at 0800 0322 308 to obtain a Return Authorization number. Customer Service will also provide a FedEx shipping number for your use to return affected product. Please package the units and ship them back to AMS immediately. Please note this recall affects only the AMS 800 Control Pumps, and does not affect AMS 800 Cuffs or Pressure Regulating Balloons.

Attached to this letter is a Product Recall Acknowledgement form. Please complete this form acknowledging receipt of this letter and state that you are returning all AMS 800 Control Pumps or that none remain at your facility. Please return this form using one of two methods: 1. Enclosed envelope, 2. Fax it to 0800 0322 307 or 020 8995 3720

It is very important that you complete and return these forms so that AMS can ensure all affected AMS 800 Control Pump product has been removed from circulation.

We believe it is important that we communicate these concerns immediately as we value our relationship with you as a provider and the trust and confidence you have placed in our solutions to treat your patients. We appreciate your understanding and patience during this recall.

Sincerely,

Whitney Erickson Senior Vice President and General Manager Men's Health Division American Medical Systems Inc.

Enclosure: AMS 800 Recall Acknowledgement Form

Report Form Field Safety Corrective Action Medical Devices Vigilance System (MEDDEV 2.1211 rev 5)

1. Administrative information Destination

Name of national competent authority (NCA) Dutch Healthcare lnspectorate Address of national competent authority P.O. Box 2680 NL - 3500 BS Utrecht Date of this report 9 May 201 1 Reference number assigned by the manufacturer FSCA for AUS 800 May 201 1 EMEA Incidence reference number and name of the co-ordinating national competent authority (if applicable) Dutch Healthcare lnspectorate Identify to what other national competent authorities this report was also sent AT;BE;CH;DE;EE;ES;FI;FR;GB;GR;IE;IT;NO;PL;PT;SE;SI;NL

2 Information on submitter of the report Status of submitter

Manufacturer [XI Authorised representative within EEA

Others (identify the role):

3 Manufacturer information Manufacturer name American Medical Systems, Inc. Manufacturer's contact person Jon Cornell Address 10700 Bren Road West Postal code 1 City 55343 Phone (920) 930-6670

4 Authorised representative information Name of the authorised representative

Minnetonka, MN Fax (952) 930-61 57

E-mail Jon.cornell@mchsi.com

Vice President & General Manager - EMEA The authorised representative's contact person

Country USA

Primary: Derrill Palidwar Address Straatwaa 66H Postal code City 3621 BR Breukelen Phone 31 346258101 Fax Phone: + Cell: 31 622 703 444 E-mail Country

I DerriII.PaIidwar@AMMD.com l ~ h e Netherlands

5 National contact point information National contact point name Country Manager Name of the contact person Keith Pelatowski Address Capital Court, Capital Interchange Way

7 Description of FSCA Background information and reason for the FSCA AMS internal D ~ O ~ U C ~ test ~rocedures were unable to confirm that all Control P u m ~ s have met

Postal code TW8 OEX Phone 020 8996 3100 E-mail Keith. Pelatowski@AMMD.com

6 Medical device information Class

AlMD Active implants

[XI MDD Class Ill (Inhibizone) IVD Annex II List A

[XI MDD Class Ilb (non-Inhibizone) IVD Annex II List B

MDD Class Ila IVD Devices for self-testing MDD Class I IVD General

Nomenclature system (preferable GMDN) GMDN Nomenclature code 35280 Nomenclature text Prosthesis, internal, urethral, sphincter Commercial namelbrand namelmake AMS 800 Control Pump Model number 724041 27 (Inhibizone); 72400098 (non-lnhibizone) Serial number(s) andlor lotlbatch number(s) Affected Lot Serial Number Range:

City Brentford Fax 020 89953720 Country UK

72404127 (with Inhibizone)

517943001 -707608020

REFlPart #

Lot Numbers

Software version number (if applicable) n/a Manufacturing datelexpiry date (if applicable) NIA

Accessorieslassociated device (if applicable) n/a Notified body (NB) ID- number 0086

72400098 (non-Inhibizone)

331544001 -708953020

specification requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activation of the control pump. Inadvertent activation of the control pump during the first eight weeks following implant could lead to urinary retention or, in a catheterized patient, could lead to tissue damage, erosion, andlor increase the risk of infection. AMS believes the likelihood of a serious adverse health consequence is remote and does not recommend explanting Control Pumps at this time.

AMS consulted a panel of urologists who recommend that patients recently implanted with Control Pumps, who are within the eight week recovery period and have a deactivated device, should be followed per standard surgical procedure. Patients should also be reminded the importance of keeping their routine follow-up appointments during the eight week post-surgical period and be advised that should they experience symptoms of retention, to contact their urologist immediately. Control Pumps that have yet to be implanted should be returned to AMS immediately. AMS has sent a separate letter to physicians providing notification and instructions for the recall.

Please note this recall affects only the AMS 800 Control Pumps, and does not affect AMS 800 Cuffs or Pressure Regulating Balloons.

Description and justification of the action (correctivelpreventive) A communication will provided to the affected Competent Authorities, Regulatory Agencies, Customers, Distributors, Physicians, and AMS employees. Product returned from the field will be scrapped.

Advice on actions to be taken by the distributor and the user AMS asks that our customers and distributors return any existing stock at AMS expense. A letter will be sent to distributors informing them of the returns process along with contact information should they have any questions.

Attached please find [XI Field Safety Notice (FSN) in English

FSN in national language Others (please specify):

Time schedule for the implementation of the different actions

9 May 201 1 These countries within the EEA and Switzerland are affected by this FSCA Within EEA and Switzerland: [XIAT [XIBE n B G [XICH O C Y O C Z H D E O D K [XIEE [XIES

Candidate Countries:

HHR BTR

All EEA, Candidate Countries and Switzerland

Others: BH, IL, LB, MA, RU, SA, ZA These countries outside the EEA and Switzerland are affected by this FSCA AR, AU, BR,CA, CL, CN, CO, CR, HK, IN, KR, MX, MY, NZ, PA, PR, SG, TH, TW, VE, US

- - - -- - -

8 Comments

I affirm that the information given above is correct to the best of my knowledge

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Signature

Jon Cornell Minnetonka, MN 55378 USA Name City

9 May 201 1 Date

Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.