BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3002729 · Received March 13, 2013

    Report

    Report Number
    3007566237-2013-00772
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 387460, LOT# VA04522, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 387460, LOT# VA04522, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: SCREENING DEVICE. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRIAL LEADS AND THEY "HAD" TO COME OUT. THE LEADS WERE NOT COMING OUT EASILY DURING THE LEAD PULL AND THERE WAS SOME RESISTANCE. THE SECOND LEAD FELT "STUCK," AND THE HEALTH CARE PROVIDER (HCP) HAD TO TRY PULLING IT A FEW TIMES. EVENTUALLY THE ELECTRODES WERE SEEN COMING OUT, BUT THE LAST TWO ELECTRODES, THE FIRST TWO AT THE TIP OF THE LEAD, DID NOT COME OUT. THE WIRE WAS EXPOSED. THE PATIENT WAS FINE AND NOTHING HAD TO BE DONE. FIVE DAYS LATER IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND HE RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104861 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1