BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 4251042 · Received November 14, 2014

    Report

    Report Number
    3007566237-2014-03335
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 3877-60, LOT# 0208593089, IMPLANTED: (B)(6) , EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ANALYSIS OF THE LEAD FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS IMPLANTED, AND AS THEY HAD THE RIGHT PLACEMENT FOR THE LEAD THE IMPEDANCE WAS CHECKED BEFORE THE LEAD WAS ANCHORED. THE IMPEDANCE VALUES WERE ABOVE 10000 OHMS ON 0.75 VOLTS. THE EXTERNAL BATTERY AND TRAILING CABLE WERE CHANGED. IMPEDANCE WAS TESTED AGAIN ON 3.0 VOLTS AND THE IMPEDANCE VALUES WERE ABOVE 40000 OHMS. A NEW LEAD WAS PLACED. THE CAUSE OF THE PRODUCT ISSUE WAS NOT DETERMINED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE LEAD WAS GOING TO BE RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738524 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR