BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2500381 · Received March 22, 2012

    Report

    Report Number
    3006630150-2012-00541
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-30, SERIAL # (B)(4). DESCRIPTION: ST LINEAR LEAD, 30CM WITH PRE-LOADED 0.014 INCH STYLET

    Additional Manufacturer Narrative · 1

    SC-2218-30, S/N #(B)(4). PHOTOGRAPHIC IMAGING REVEALED THAT ELECTRODES #7 & #8 AT THE DISTAL END HAS A FRACTURED CABLE RIGHT AT THE WELD NUGGET. REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE LEAD PASSED QUALITY INSPECTION AND NO ANOMALIES WERE FOUND DURING ITS PRODUCTION. THE ROOT CAUSE OF LEAD FRACTURE IS UNKNOWN. SC-2218-30, S/N #(B)(4) THE LEAD SHOWED THAT THE LEAD INSULATION WAS CUT APPROXIMATELY 8 INCHES FROM DISTAL TIP. THE CABLE THAT IS CONNECTED TO CONTACT #8 IS CUT RIGHT AT THE DAMAGED LOCATION. ELECTRICAL TEST CONFIRMED THAT CONTACT #8 IS OPEN DUE TO THIS DAMAGE. IT WAS REPORTED THAT THE LEAD WAS CUT DURING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE. THE PHYSICIAN REPLACED THE LEADS. THE PATIENT IS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE. THE PHYSICIAN REPLACED THE LEADS. THE PATIENT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention