BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1942064 · Received November 9, 2010

    Report

    Report Number
    3006630150-2010-01849
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD REVISION, THE PT IS EXPERIENCING CHARGING DIFFICULTY. A BSN REPRESENTATIVE ANALYZED THE PT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR