BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS SUTURELESS MYOCARDIAL LEAD

    MDR report key: 26086 · Received August 9, 1995

    Report

    Report Number
    2124215-1995-00060
    Event Type
    Injury
    Date Received
    August 9, 1995
    Date of Event
    July 27, 1995
    Report Date
    August 9, 1995
    Manufacturer
    POSSIS MEDICAL INC.
    Product Code
    FSA
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN IMPLANT FORM STATING THAT THIS LEAD AND ANOTHER MODEL 4320 LEAD. SERIAL NUMBER 012252. WERE REMOVED FROM SERVICE BECAUSE "DAMAGED DURING INCISION-CAPPED." IMPLANTED-1/2/92. REMOVEDW FROM SERVICE-7/27/95. TOWTAL IMPLANT TIME-42 MO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS SUTURELESS MYOCARDIAL LEAD LEAD FSA POSSIS MEDICAL INC. 4320 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *