BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1030619 · Received April 16, 2008

    Report

    Report Number
    2029203-2008-00234
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED INTERMITTENT STIMULATION, AFTER UNDERGOING A SPINAL FUSION. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE SPINAL FUSION. THE SURGEON DECIDED TO REPLACE THE PT'S SYSTEM. DEVICE LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP. SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| SC-2138-70| EXPLANTED:| SC-2138-70