BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3113833 · Received May 15, 2013

    Report

    Report Number
    3007566237-2013-01624
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION SERIAL: (B)(4), IMPLANTED: NA, EXPLANTED: NA. (B)(4). FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED NO ANOMALY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EXTENSION DID NOT FIT TO THE EXISTING ELECTRODE. THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT # 3007566237-2013-01579. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT #3007566237-2013-01624.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO CONNECT THE LEAD TO THE STIMULATOR, THERE WERE HIGH IMPEDANCES. THE LEAD WAS CONNECTED TO AN EXTENSION, AND THE IMPEDANCES WERE REPORTED TO BE TOO HIGH. AFTER SEVERAL ATTEMPTS OF DISCONNECTING AND RECONNECTING, IT WAS DECIDED TO USE ANOTHER EXTENSION. THE STIMULATOR WAS NOT REPLACED. THE PATIENT WAS NOTED TO HAVE NO INJURY AND TO BE "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214361 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR