BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1243696 · Received November 25, 2008

    Report

    Report Number
    2029203-2008-00881
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    August 1, 2005
    Report Date
    October 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    2029203-09/19/08-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD RECEIVED BURNS FROM HIS CHARGER. THE FIRST BURN HAD BLISTERS AND THE SECOND AND THIRD BURN LEFT REDNESS AT THE BATTERY SITE. THE BURNS HAVE SINCE HEALED AND 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