BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS SUTURELESS MYOCARDIAL LEAD

    MDR report key: 28845 · Received November 17, 1995

    Report

    Report Number
    2124215-1995-00102
    Event Type
    Injury
    Date Received
    November 17, 1995
    Date of Event
    November 2, 1995
    Report Date
    November 16, 1995
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED INFO THAT THIS LEAD, SERIAL NUMBER 012888 AND SN 012883 WERE REMOVED FROM SVC FOR INSULATION FAILURE. CO ALSO RECEIVED INFO THAT TWO LARGE PATCH LEADS LEADS MODEL 0041. SN 205089 AND SN 204901 WERE ALSO REMOVED FROM SVC FOR INSULATION FAILURE. A SERIOUS INJURY REPORT WAS FILED ON THE MODEL 0041. IMPLANT DATE 1/27/92. OUT OF SVC DATE 11/2/95. TOTAL IMPLANT TIME - 45 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention