FDA Device Recall Z-0037-2008: Medtronic Neuromodulation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0037-2008.

Recall Res Number

Z-0037-2008

Recalling Firm / Manufacturer

Medtronic Neuromodulation

FEI Number

2182207

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-06-25

Date Posted

2007-10-11

Date Terminated

2010-10-08

Product Code

EZW

Event Number

38371

Product Quantity

1885

Product Description Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.

Reason for Recall A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

Action Details Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient mangement of the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.

Distribution Pattern Nationwide and the Netherlands.

Code Information / Serial Numbers All serial numbers within these catalog/model numbers are affected: Model 3058, Catalog # 8870MM01 & 8870NNB01

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1319639 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
TECHNICAL SERVICES FOR ELECTRONICS, INC. Registration: 2135338 View Registration
MEDTRONIC NEUROMODULATION Registration: 2182207 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA Registration: 2649622 View Registration
AXONICS, INC. Registration: 3002968685 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS Registration: 3004209178 View Registration
Plexus Manufacturing Sdn. Bhd. Registration: 3004593495 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
Cirtec Medical Registration: 3009183442 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3010972758 View Registration
NEUSPERA MEDICAL, INC. Registration: 3014845032 View Registration
BOULDER BIOMED LLC Registration: 3015151147 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
Saluda Medical Pty. Ltd. Registration: 3021836309 View Registration

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Medical Device Recall: Z-0037-2008

Recall Parameters & Description

Related Establishments / Registrations

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