BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3914704 · Received July 3, 2014

    Report

    Report Number
    3006630150-2014-01512
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF DISLODGED ELECTRODES WAS CONFIRMED. VISUAL INSPECTION REVEALED ALL ELECTRODES EXCEPT FOR THREE ELECTRODES WERE MISSING AND NOT RETURNED. THREE ELECTRODES WERE STILL ATTACHED TO THEIR RESPECTIVE CABLES AND PROPERLY EMBEDDED IN THE PADDLE SILICONE. THE ROOT CAUSE OF THE ELECTRODE DISLODGEMENT IS UNKNOWN. THE LEAD COULD NOT BE ELECTRICALLY TESTED SINCE IT WAS RETURNED WITH BOTH PIGTAILS CLEANLY CUT FROM THE PADDLE END. THE CUT PROXIMAL PORTIONS OF THE LEAD WERE NOT RETURNED. THE CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT WAS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING REPROGRAMMING HIGH IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE, DURING WHICH, IT WAS FOUND THAT 13 OUT OF THE 16 CONTACTS WERE DISLODGED FROM THE LEAD AND FELL OFF IN THE EPIDURAL SPACE AS CONFIRMED BY X-RAY. THE PHYSICIAN SUSPECTED MALFUNCTION WITH THE LEAD AND THE LEAD WAS REPLACED. ALL CONTACTS WERE RETRIEVED FROM THE PATIENT¿S BODY. THE PATIENT WAS GETTING GREAT COVERAGE AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING REPROGRAMMING HIGH IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE, DURING WHICH, IT WAS FOUND THAT 13 OUT OF THE 16 CONTACTS WERE DISLODGED FROM THE LEAD AND FELL OFF IN THE EPIDURAL SPACE AS CONFIRMED BY X-RAY. THE PHYSICIAN SUSPECTED MALFUNCTION WITH THE LEAD AND THE LEAD WAS REPLACED. ALL CONTACTS WERE RETRIEVED FROM THE PATIENT¿S BODY. THE PATIENT WAS GETTING GREAT COVERAGE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391739 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention