BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3202749 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01384
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    B3: 2012. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2108-50M, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE, MODEL #: SC-1110, SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. DEVICE EVALUATION INDICATED THAT THE LEAD (B)(4)PASSED VISUAL, ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. IPG: THE FUNCTIONAL TESTS WERE PERFORMED TO ENSURE THE DEVICE'S FUNCTIONALITY. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. LEAD (B)(4): VISUAL AND X-RAY INSPECTIONS WERE PERFORMED TO ENSURE THE DEVICE INTEGRITY. IMPEDANCE MEASUREMENTS WERE WITHIN THE NORMAL RANGE. NO ANOMALIES WERE FOUND. LEAD (B)(4): AS NO ANOMALIES OR DEVIATIONS WERE FOUND DURING THE COMPLAINT INVESTIGATION SITE (CIS) REVIEW, THERE IS NO REASON TO SUSPECT A MANUFACTURING DEFECT AS THE SOURCE OF THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2108-70M, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD WAS DISPLAYING HIGH IMPEDANCES DUE TO A SUSPECTED LEAD FRACTURE/MALFUNCTION. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S SCS SYSTEM GRADUALLY LOST ITS EFFICACY. THE IPG WAS FOUND TO BE NEARLY EXPIRED, AND THE LEAD HAD A SUSPECTED LEAD FRACTURE. THE PHYSICIAN BELIEVED THAT THE SYSTEM WAS UNSALVAGEABLE, SO THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD WAS DISPLAYING HIGH IMPEDANCES DUE TO A SUSPECTED LEAD FRACTURE/MALFUNCTION. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303004 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2108-50M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention