Recall Z-0998-2022 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
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
| Date | Apr 22, 2022 (initiated Feb 28, 2022) |
| Status | Terminated |
| 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. |
| Root cause | Software Design Change |
| Action | Medtronic distributed a correction notice to impacted U.S. implanting physicians, who had implanted patients with the Model 97800 InterStim X system prior to the release of the software update or purchased the TH90Q kit (in addition to notifying, Medtronic Sales Representatives and Medtronic Patient & Technical Services) on 28-Feb-2022. Medtronic distributed a correction notice to impacted U.S. hospital accounts, who have purchased the TH90Q kit containing the affected HH90 handset prior to the software updated release, on 04-Mar-2022, notifying consignees of this issue and the software updat |
| Quantity | 1005 units |
| Distribution | US Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY, AR, MO, MN, OH, CO, KS, MS, SC, LA, WA, PA, IN, SD, MI, WV, AL, GA, TN, VA, IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.