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