BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2930984 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00286
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3878-45, LOT# 0205441452, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCES GREATER THAN 10000 OHMS ON ELECTRODE ONE, WHICH WAS THE ONLY ELECTRODE PROGRAMMED AS NEGATIVE. THE PATIENT WAS REPROGRAMMED. IT WAS REPORTED THAT SYMPTOMS INCLUDED THE PATIENT NOT HAVING PARESTHESIAS. IT WAS NOTED THAT AFTER REPROGRAMMING USING DIFFERENT ELECTRODES THE SAME PARESTHESIA COVERAGE WAS FOUND. THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37209 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR