BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3021168 · Received March 26, 2013

    Report

    Report Number
    3006630150-2013-00529
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    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 PADDLE LEAD PASSED PHOTOGRAPHIC IMAGING TEST PERFORMED. THE VISUAL INSPECTION REVEALED THAT BODY OF THE PADDLE END HAS BEEN SEVERELY DAMAGED. THE SILICON OF PADDLE END IS TORN APPROXIMATELY AT MIDSECTION. FIVE ELECTRODES ARE COMPLETELY DISLODGED AND FOUR ARE MISSING FROM THE PADDLE. THE ROOT CAUSE OF THE PADDLE DAMAGE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE FOUR MISSING CONTACTS WERE NOT FOUND INSIDE THE PATIENT'S BODY THROUGH X-RAY. THE MISSING CONTACTS WERE NOTICED DURING THE PROCEDURE AND THE PADDLE LEAD WAS FRACTURED PRIOR THE REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DID NOT GET ADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE PADDLE LEAD WAS REPLACED WITH PERCUTANEOUS LEADS DUE TO A SUSPECTED LEAD FRACTURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DID NOT GET ADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE PADDLE LEAD WAS REPLACED WITH PERCUTANEOUS LEADS DUE TO A SUSPECTED LEAD FRACTURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DID NOT GET ADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE PADDLE LEAD WAS REPLACED WITH PERCUTANEOUS LEADS DUE TO A SUSPECTED LEAD FRACTURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124114 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR