BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC POWER SUPPLY

    MDR report key: 1764174 · Received July 20, 2010

    Report

    Report Number
    2939204-2010-00789
    Event Type
    Injury
    Date Received
    July 20, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510# - K021494 AND K951256.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO SACRIFICE A VERTEBRAL ARTERY THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN THE GROIN FROM THE GROUNDING NEEDLE DURING COIL DETACHMENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC POWER SUPPLY DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - FREMONT UNK105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other