BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STIMULATOR

    MDR report key: 6356274 · Received February 24, 2017

    Report

    Report Number
    3007566237-2017-00774
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Report Date
    April 19, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERSTIM IS NO LONGER APPLICABLE TO THE EVENT. EZW IS NO LONGER APPLICABLE TO THE EVENT . PMA H990014 IS NO LONGER APPLICABLE TO THE EVENT.

    Description of Event or Problem · 1

    A MANUFACTURING REPRESENTATIVE (REP) REPORTED ON BEHALF OF A HEALTHCARE PROVIDER (HCP) THAT A PATIENT STATED THEY HAD A FEW FRIENDS THAT WERE COMPLAINING OF THE SAME ISSUE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNING. THERE WAS NO OTHER INFORMATION AVAILABLE AT THE TIME OF THE REPORT. THE INS INDICATION FOR USE WAS NOT CLEAR AT THE TIME OF THE REPORT. PLEASE SEE RR 3004209178-2017-04430 WHERE INFORMATION WAS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138479 UNKNOWN STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1