Paired VNS 3000 (UDI 10810041430080)Recalls & reported problems

Microtransponder · Lead, 3 mm cuff · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10810041430080), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE ORIGINAL IMPLANTATION OF THE VIVISTIM SYSTEM OCCURRED ON (B)(6) 2024 (THAT SURGEON IS NO LONGER AT THAT HOSPITAL). ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION OF THE NECK INCISION AT THE LEAD INSERTION SITE BY A DIFFERENT SURGEON AT A DIFFERENT HOSPITAL THAT HAS PREVIOUSLY IMPLANTED THE VIVISTIM SYSTEM WITH OTHER PATIENTS. MICROTRANSPONDER INC. (MTI) INCLUDES FOUR TIE-DOWNS IN THE LEAD PACKAGING TO SECURE THE LEAD IN PLACE. IT WAS REPORTED, THAT ONE OF THE TIE-DOWNS APPEARED TO BE PUSHING AGAINST THE SURFACE OF THE SKIN, SHOWING A SMALL BUMP VISIBLE TO THE PATIENT. THE SURGEON REOPENED THE INCISION AND REMOVED THE TIE-DOWN. SUBSEQUENT TESTING OF BOTH THE LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) CONFIRMED THAT THEY WERE FUNCTIONING AS INTENDED. THE TIE DOWN WAS DISPOSED OF AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23054224 ↗

Device details

UDI-DI	`10810041430080`
Brand	Paired VNS
Model	3000
Company	Microtransponder
Product code	QPY · Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
Class	Class 3
FDA submission	P210007
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	May 9, 2022

Device type (GMDN): Vagus nerve electrical stimulation system lead

An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).

Other Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation devices

Vivistim® 1001
Microtransponder · Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
37 reports
Paired VNS 3000
Microtransponder · Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
3 reports

All Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page