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).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- May 15, 2019
- Posted
- June 7, 2019
- Recall Number
- Z-1774-2019
- Quantity
- 13979 units
- Firm Location
- Minneapolis, MN
Reason for Recall
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Distribution
Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands
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
Root Cause
Software design
Action Taken
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.