Z-0561-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2020
- Initiation Date
- August 22, 2019
- Termination Date
- March 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1687
Product Description
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Reason for Recall
Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
Distribution Pattern
U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT
Code Information
Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.