BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA®

    MDR report key: 4579048 · Received March 6, 2015

    Report

    Report Number
    3006630150-2015-00596
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 6, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF SC-2136-50 S/N (B)(4) INDICATED THAT THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT WAS CONFIRMED. VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THIS LOCATION APPEARED TO BE THE SITE WHERE THE SUTURE WAS POSITIONED. ADDITIONAL VISUAL INSPECTION FOUND THAT THE LEAD BODY WAS KINKED AT THE PROXIMAL END OF THE RETENTION SLEEVE. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL #:(B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE DUE TO HIGH IMPEDANCES ON ONE LEAD. DEVICE MALFUNCTION WAS NOT SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A LEAD REVISION PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE DUE TO HIGH IMPEDANCES ON ONE LEAD. DEVICE MALFUNCTION WAS NOT SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156876 SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention