BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1040519 · Received May 9, 2008

    Report

    Report Number
    2029203-2008-00288
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    SHORTLY AFTER IMPLANT OF THE TRIAL, LEADS LOW IMPEDANCES WERE OBSERVED. THE SURGEON BELIEVED THE PT'S DURA MAY HAVE BEEN PUNCTURED DURING IMPLANT. THE PT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-2138-50T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention