BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1111908 · Received August 12, 2008

    Report

    Report Number
    2029203-2008-00556
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 14, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED THAT THE PT WAS SUFFERING FROM HEADACHES SHORTLY AFTER TRIAL LEAD IMPLANT PROCEDURE. THE SURGEON BELIEVED THAT THE PT'S DURA WAS PUNCTURED DURING AND EXPLANTED PRECISION TRIAL LEADS. ALSO REFER TO MDR NO. 2029203-2008-00529.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP. SC-2208-50T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R