Recalls / —
—#172112
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).
- FDA product code
- EZW — Stimulator, Electrical, Implantable, For Incontinence
- Device class
- Class 3
- Medical specialty
- Gastroenterology, Urology
- PMA numbers
- P970004S268, P080025S163
- Affected lot / code info
- Model Numbers/UDI: a) TH90G01/00763000058005 b) TH90GFA/00763000187231 c) TH90G02/00763000192259, 00763000192266, 00763000192273, 00763000192280, 00763000192297, 00763000192303, 00763000192310 d) TH90G03/00763000192310 ALL LOT/SERIAL NUMBERS
Why it was recalled
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Root cause (FDA determination)
Software design
Action the firm took
Medtronic sent an Urgent Medical Device Safety Notification letter dated May 2019, to US Physicians and European physician. The notifications were delivered by mail, personal delivery by Medtronic Representatives, fax, or equivalent method. A confirmation form will be used to document receipt and understanding of the notification, and a minimum three attempts will be made to obtain confirmation from non-responding physicians that the notification has been received and understood.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands
Timeline
- Recall initiated
- 2019-05-15
- Posted by FDA
- 2019-06-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #172112. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.