BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1250414 · Received December 3, 2008

    Report

    Report Number
    2029203-2008-01043
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE EVALUATED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT COULD FEEL HER IMPLANT COMING THROUGH HER SKIN. THE PHYSICIAN EXPLANTED THE BATTERY AND WASN'T SURE IF THE PATIENT HAD AN INFECTION OR IF THE PATIENT'S SKIN WAS JUST THINNING. A CULTURE WAS TAKEN AND INDICATED THAT THE PATIENT HAD A STAPH INFECTION. 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-1110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R LINEAR LEAD 70CM (PHASE II): MODEL # SC-2108-70M