BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3954024 · Received July 23, 2014

    Report

    Report Number
    3006630150-2014-01681
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT THE LEAD WAS FRACTURED WAS CONFIRMED. VISUAL INSPECTION FOUND LUMEN DAMAGE AND FRACTURED CABLES 5 CM FROM THE PADDLE END. THE ROOT CAUSE OF THE DAMAGED IS UNKNOWN. ADDITIONALLY, VISUAL INSPECTION REVEALED THAT ALL ELECTRODES WERE PARTIALLY DISLODGED, BUT STILL ATTACHED TO THEIR RESPECTIVE CABLES. THE ROOT CAUSE OF THE DISLODGEMENT OF ELECTRODES IN UNKNOWN. THE LEAD BODIES WERE CLEANLY CUT IN MULTIPLE PLACES AND THE MULTI LUMEN OUTER TUBING IS REMOVED FROM THE CABLES. THE CLEAN CUT DAMAGED WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE RELATED AND IT IS NOT CONSIDERED A FAILURE. THE PROXIMAL PORTION OF THE PADDLE LEAD IS NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD WAS FRACTURED AND WAS BRITTLE. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN CLARIFIED THAT THE LEAD FRACTURE AND BRITTLE DID NOT APPEAR NEAR THE SUTURE AND THAT IT WAS NOT NOTICED AFTER THE EXPLANT. IT APPEARED TO BE A DEFECTIVE LEAD INSTALLATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD WAS FRACTURED AND WAS BRITTLE. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN CLARIFIED THAT THE LEAD FRACTURE AND BRITTLE DID NOT APPEAR NEAR THE SUTURE AND THAT IT WAS NOT NOTICED AFTER THE EXPLANT. IT APPEARED TO BE A DEFECTIVE LEAD INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430832 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention