BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2883281 · Received December 21, 2012

    Report

    Report Number
    3007566237-2012-03092
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD EXPERIENCED AN OVERSTIMULATION SENSATION FOLLOWING A REPROGRAMMING SESSION AT HIS CLINIC WHERE "ONLY THE UPRIGHT POSITION ELECTRODES HAD BEEN CHANGED, AND EVERYTHING ELSE HAD STAYED THE SAME BUT THE OTHER POSITIONS HAD NOT BEEN PROGRAMMED." THE PATIENT FELT FINE IN THE OFFICE AND WALKING OUT TO HIS CAR BUT WHEN HE WENT TO GET INTO THE CAR, HE FELT THAT HIS IMPLANTABLE NEUROSTIMULATOR (INS) WAS "FRYING HIM." LESS THAN TWO WEEKS LATER IT WAS REPORTED THAT NO DIAGNOSTICS HAD BEEN PERFORMED. THE PATIENT WAS KEEPING THE INS OFF AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1