BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3242826 · Received July 23, 2013

    Report

    Report Number
    3006630150-2013-01561
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD PASSED THE MECHANICAL TESTS PERFORMED. THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION OF LEAD (SC-2218-70 / (B)(4)) REVEALED A CLEAN CUT IN THE MULTI LUMEN OUTER TUBING AND FOUR SEVERED CABLES FROM THE DISTAL END. DAMAGE TO THE LEAD WAS A RESULT OF THE REVISION, AND IT WAS NOT CONSIDERED A FAILURE. THE EXPLANTED LEAD (SC-2218-70 / (B)(4)) WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ONE OF THE PATIENT'S LEAD WAS PRODUCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEAD WAS REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ONE OF THE PATIENT'S LEAD WAS PRODUCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342661 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR