BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 898823 · Received August 20, 2007

    Report

    Report Number
    2029203-2007-00756
    Event Type
    Injury
    Date Received
    August 20, 2007
    Date of Event
    July 30, 2007
    Report Date
    July 30, 2007
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LEAD PLACEMENT PROCEDURE, IT WAS CONFIRMED THAT THE PATIENT HAD A DURA PUNCTURE. THE PATIENT WAS ADMINISTERED FLUIDS AND THE PHYSICIAN PRESCRIBED MEDICATION FOR HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW ADVANCED BIONICS CORP. SC-2138-50T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention SC-2138-50T