BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5091047 · Received September 21, 2015

    Report

    Report Number
    3007566237-2015-02673
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    January 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT, AFTER SURGERY FOR IMPLANT IN 2013, THE MANUFACTURER REPRESENTATIVE (REP) CHECKED THE DEVICE AND THE PATIENT HEARD THE REP TELL THE HEALTHCARE PROVIDER (HCP) THAT "NONE OF THESE ARE WORKING" AND THE HCP SAID "YEAH, YOU'RE RIGHT." RELEVANT MEDICAL HISTORY INCLUDED CERVICAL RADICULOPATHY. FOLLOW-UP WAS NOT POSSIBLE AS THE PATIENT DID NOT KNOW THE REP'S NAME AND NO DEVICE WAS REGISTERED FOR THE PATIENT AT THE ALLEGED TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622389 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1