May

2022

Recall – Interstim therapy system fails to retain patient information fields

Company: Medtronic Neuromodulation
Date of Enforcement Report: 5/4/2022
Class II

PRODUCT

MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x “My Therapy” Patient Therapy Application Software, Model Number A52300

Recall Number:

Z-0998-2022

REASON

There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a ” Data Lost” notification being displayed.

RECALLING FIRM/MANUFACTURER

Medtronic Neuromodulation on 2/28/2022. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

1005 units

DISTRIBUTION

U.S. Nationwide

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Recall – Interstim therapy system fails to retain patient information fields

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