BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4061766 · Received September 4, 2014

    Report

    Report Number
    3006630150-2014-02023
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-2316-50 (SN:(B)(4)) THE COMPLAINT WAS CONFIRMED. A PRONOUNCED KINK WAS NOTED AT THE CLIK ANCHOR SITE OF LEAD. X-RAY INSPECTION REVEALED BROKEN CABLES 1 CM FROM WHERE THE CLIK ANCHOR WAS TIGHTENED. ALL CABLES WERE VERIFIED TO BE OPEN. THIS DAMAGE MIGHT BE THE SOURCE OF THE REPORTED STIMULATION AND IMPEDANCE ANOMALIES. THERE ARE NO EXPOSED CABLES. SC-1132 (SN:(B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE DEVICE WAS WORKING AS EXPECTED. SC-2316-50(SN:(B)(4)) DEVICE EVALUATION INDICATED THAT THE LEAD PASSED VISUAL, ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. NO ANOMALIES WERE FOUND. SC-3400-30 (SN:(B)(4)) NO ANOMALIES WERE FOUND. SC-4316 (LN:16396112) NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION: INFINION1X16 PERC LEAD KIT-50 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3400-30, SERIAL/LOT #: (B)(4)/528860, DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM). MODEL #: SC-4316, SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INCREASED PAIN AT THE IPG SITE WHETHER THE DEVICE WAS TURNED ON OR OFF AND WAS EXPERIENCING INTERMITTENT AND INADEQUATE STIMULATION. DEVICE INTERROGATION REVEALED HIGH IMPEDANCES ON THE RIGHT LEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INCREASED PAIN AT THE IPG SITE WHETHER THE DEVICE WAS TURNED ON OR OFF AND WAS EXPERIENCING INTERMITTENT AND INADEQUATE STIMULATION. DEVICE INTERROGATION REVEALED HIGH IMPEDANCES ON THE RIGHT LEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INCREASED PAIN AT THE IPG SITE WHETHER THE DEVICE WAS TURNED ON OR OFF AND WAS EXPERIENCING INTERMITTENT AND INADEQUATE STIMULATION. DEVICE INTERROGATION REVEALED HIGH IMPEDANCES ON THE RIGHT LEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540385 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention