Medtronic Neuromodulation: Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

Hazard

A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

Details from the source

Reason for recall: A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures. Distribution: Worldwide distribution. Quantity: 3791 devices Lot/code info: GTIN 00763000411923, Serial/Lot Numbers: NMS504094H, NMS504258H, NMS504861H, NMS503154H, NMS503612H, NMS503371H, NMS503748H, NMS504643H, NMS504701H, NMS504404H, NMS504802H, NMS504344H, NMS504771H, NMS504778H, NMS504650H, NMS501450H, NMS504544H, NMS501538H, NMS503203H, NMS503064H, NMS501373H, NMS503404H, NMS504791H, NMS504792H, NMS501978H, NMS502528H, NMS501313H, NMS501469H, NMS503521H, NMS502644H, NMS504254H, NMS502974H, NMS504955H, NMS503078H, NMS503079H, NMS504657H, NMS501285H, NMS501484H, NMS504381H, NMS501266H, NMS502517H, NMS502681H, NMS504772H, NMS501163H, NMS504243H, NMS502056H, NMS504636H, NMS505065H, NMS503237H, NMS501226H, NMS502346H, NMS502407H, NMS503392H, NMS503395H, NMS504259H, NMS504337H, NMS504402H, NMS504606H, NMS504610H, NMS505010H, NMS505012H, NMS505013H, NMS505014H, NMS505015H, NMS503450H, NMS504406H, NMS505034H, NMS504527H, NMS501897H, NMS504444H, NMS504523H, NMS504981H, NMS503627H, NMS502402H, NMS503862H, NMS501278H, NMS501953H, NMS502022H, NMS504561H, NMS504740H, NMS504825H, NMS505032H, NMS503326H, NMS501135H, NMS502277H, NMS502454H, NMS501656H, NMS503278H, NMS504220H, NMS504847H, NMS502102H, NMS503307H, NMS504371H, NMS504859H, NMS501491H, NMS501512H, NMS501557H, NMS502447H, NMS502504H, NMS502682H, NMS502759H, NMS502933H, NMS502959H, NMS502983H, NMS502984H, NMS503141H, NMS503336H, NMS503340H, NMS503525H, NMS503527H, NMS503530H, NMS503726H, NMS503727H, NMS504032H, NMS504033H, NMS504124H, NMS504130H, NMS504433H, NMS504438H, NMS504453H, NMS504489H, NMS5045

UPC codes

00763000411923, 00763000478087

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.