BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS MYOCARDIAL SUTURELESS LEAD

    MDR report key: 134114 · Received November 19, 1997

    Report

    Report Number
    2124215-1997-09260
    Event Type
    Injury
    Date Received
    November 19, 1997
    Date of Event
    October 24, 1997
    Report Date
    November 3, 1997
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR RECEIVED INFO THAT THIS PMI LEAD WAS REMOVED FROM SERVICE DUE TO AN INSULATION BREAK. THE LEAD WAS REPLACED WITH A NEW RATE SENSING LEAD. TWO PMI LEADS WERE INVOLVED IN THE PT'S LEAD SYSTEM. DISTRIBUTOR IS UNABLE TO DETERMINE WHICH LEAD WAS INVOLVED AND THEREFORE WILL REPORT ON 113625 AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS MYOCARDIAL SUTURELESS LEAD Implant MYOCARDIAL LEAD LWS POSSIS MEDICAL, INC. 1114 11362

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention