BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1922637 · Received November 12, 2010

    Report

    Report Number
    3006630150-2010-01921
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT, DURING A REPROGRAMMING SESSION, THE BSN REPRESENTATIVE NOTICED THAT THE PROXIMAL END OF THE TRIAL PATIENT'S LEAD HAD BROKEN. THE LEAD HAD BROKEN WHEN THE PATIENT PULLED IT OUT OF THE OPERATING ROOM CABLE BOX. THE WIRES WERE EXPOSED FROM THE REMAINING 3 CONTACTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK