BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1850884 · Received September 28, 2010

    Report

    Report Number
    3006630150-2010-01635
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT HAD DEVELOPED A SMALL EPIDURAL HEMATOMA. THE PT REPORTED WEAKNESS IN HER LEGS. THE PHYSICIAN OPENED THE INCISION, TOOK THE PADDLE LEAD OUT, EVACUATED ANY BLOOD, AND REPLACED THE PADDLE LEAD. THE PHYSICIAN INSERTED A DRAIN TO INSURE ALL BLOOD WAS EVACUATED. THE PHYSICIAN IS UNSURE OF THE REASON FOR THE HEMATOMA, BUT NOTED THAT THE PT HAD A LOT OF SCAR TISSUE. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention