BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1024304 · Received April 3, 2008

    Report

    Report Number
    2029203-2008-00182
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROGRAMMING SESSION, THE LEAD EXHIBITED HIGH IMPEDANCE READINGS. DURING AN EXPLORATORY PROCEDURE, IT WAS DETERMINED THAT THE LEAD WAS FRACTURED. THE PATIENT'S SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| SC-1110