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Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with A...

FDA Device Recall #Z-1600-2016 — Class II — April 6, 2016

Recall Summary

Recall Number Z-1600-2016
Classification Class II — Moderate risk
Date Initiated April 6, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nuvectra
Location Blaine, MN
Product Type Devices
Quantity 17 OUS

Product Description

Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs

Reason for Recall

If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.

Distribution Pattern

Germany

Lot / Code Information

Serial 000010 000011 FF0043 FF0045 000014 000015 000016 FF0054 FF0048 FF004B FF005D FF0064 FF0065 FF0067 FF00A9 FF00AD FF00BB Lot P178713 P185700 P187989 P195875 P213108 P257056

Other Recalls from Nuvectra

Recall # Classification Product Date
Z-0781-2017 Class II Algovita Spinal Cord Stimulation System, Percu... Oct 11, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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