BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1760556 · Received July 14, 2010

    Report

    Report Number
    3006630150-2010-01166
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS HAVING SKIN EROSION AT THE POCKET SITE AND THE SKIN WAS GETTING THIN AND ERODING. THE PT COMPLAINED OF INTENSE HEAT AND BURNING SENSATIONS WHILE CHARGING THE IMPLANT. THE PT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN REVISED THE PT POCKET. THE PT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE AND IS NOT EXPERIENCING ANY BURNING SENSATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention