BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1063551 · Received June 20, 2008

    Report

    Report Number
    2029203-2008-00411
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    June 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LEAD REVISION PROCEDURE, THE SURGEON DISCOVERED THAT THE LEAD WAS FRACTURED. THE DAMAGED LEAD WAS REPLACED WITH A NEW BOSTON SCIENTIFIC SPINAL CORD STIMULATOR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORP. SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SC-2138-70