Recall – VNS Therapy devices experience unexpected reset, CL I

Company: LivaNova USA Inc
Date of Enforcement Report: 1/1/2020
Class I

PRODUCT

VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

  • Recall Number: Z-0561-2020

REASON

Certain Model 1000 generators (SN = 100,000) have experienced unexpected device resets, which resulted in disablement of therapy. Fourteen (14) complaints have been reported. Each of the device resets occurred within 60 days of enabling therapy. Once the device is disabled, therapy can be re-enabled, but the device will continue to be susceptible to resets. If a device experiences this issue and is disabled, patients may return to baseline seizure or depressive symptoms.

RECALLING FIRM/MANUFACTURER

LivaNova USA Inc. on 8/22/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2909 devices

DISTRIBUTION

Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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