—#184732

Product

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Software version 1.3.80

Why it was recalled

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Medtronic notified the first consignee by letter on 11/12/2020 with a confirmation of their complaint and request to perform a correction to the device which put the device in a factory-reset state and restore functionality to allow programming and continued therapy. On 17 Dec 2020, Medtronic will begin issuing an Urgent Medical Device Correction notification to physicians regarding this validation error and providing instructions on the impact and appropriate mitigating actions if this issue presents.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.

Timeline

Recall initiated: 2020-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.