BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2931832 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00299
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 387745, LOT# B0803508K, IMPLANTED: (B)(6) 200, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD MODEL 387745 LOT B0803508K FOUND ALL CONDUCTORS WERE BROKEN 12.1CM FROM THE DISTAL END. THE LEAD APPEARED TO HAVE BEEN BENT AT THIS LOCATION. THE STYLET COIL COATING WAS BROKEN AT THE LOCATION OF THE CONDUCTOR BREAKS. ALL CIRCUITS WERE OPEN.

    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 ALL CONTACTS ON THE LEAD SHOWED HIGH IMPEDANCES, GREATER THAN 10,000 OHMS, AND THE PATIENT COULD NO LONGER FEEL PARESTHESIA. IT WAS SUSPECTED THAT THE PLACE OF FIXATION (TITAN ANCHOR) CAUSED A LEAD BREAKAGE ALTHOUGH FIXATION WAS DONE CORRECTLY. THE LEAD WAS EXPLANTED AND REPLACED WITH CORRECT PARESTHESIA COVERAGE. THERE WAS NO PATIENT INJURY BUT SURGICAL REVISION WAS REQUIRED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF FAILED BACK SURGERY SYNDROME SINCE 2006. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38280 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention