BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1150234 · Received September 3, 2008

    Report

    Report Number
    2029203-2008-00576
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC8120-70. DESCRIPTION - ARTISAN 2X PADDLE LEAD (WITH SLOTTED ELECTRODES). THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING HEADACHES AND TENDERNESS AROUND THE LEADS. THE DR DETERMINED THE CAUSE TO BE A DURA PUNCTURE. THE DURA PUNCTURE WAS SURGICALLY REPAIRED. THE DR STATES THAT THE DURA PUNCTURE IS NOT DEVICE RELATED BUT A RANDOM INCIDENT. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-8116-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention