BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1843694 · Received September 22, 2010

    Report

    Report Number
    3006630150-2010-01643
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT FELL ON THE IMPLANT SITE. THE FALL WAS NOT DEVICE RELATED, BUT THE PT'S STIMULATION CHANGED IMMEDIATELY. A BSN SALES REPRESENTATIVE MET WITH THE PT FOR TROUBLESHOOTING AND HIGH IMPEDANCES WERE OBSERVED. THE PT'S PHYSICIAN BELIEVES THE LEAD MAY HAVE DETACHED FROM THE HEADER OF THE IPG AND HAS RECOMMENDED A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention