19

Jun

2019

Recall – Smart programmer has potential for unexpected behavior

recall, softwareerror

0

Company: Medtronic Neuromodulation
Date of Enforcement Report: 6/19/2019
Class II

PRODUCT

InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

Recall Number: Z-1774-2019

REASON

There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic’s smart programmer).

RECALLING FIRM/MANUFACTURER

Medtronic Neuromodulation on 6/19/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13979 units

DISTRIBUTION

US Nationwide and International

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