BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1260089 · Received December 10, 2008

    Report

    Report Number
    2029203-2008-01066
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    September 1, 2008
    Report Date
    November 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    Z-0271-2009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED THAT A PATIENT HAD BURNED HIMSELF WHILE CHARGING. A TOPICAL CREAM WAS USED TO HEAL THE BURN. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-5300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention