MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Mode

FDA device recall Z-0998-2022 · posted 2022-04-22 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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.

Action taken

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 update availability. Medtronic will also notify those consignees with the TH90PFA and TH90GFA kits where the affected software was installed.

Root cause

Software Design Change

Status

Open, Classified

Product code

EZW

Quantity affected

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.

Date initiated

2022-02-28

Date posted

2022-04-22

Location

Minneapolis, MN