BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTRAK MINI III AICD

    MDR report key: 266373 · Received February 22, 2000

    Report

    Report Number
    MW1018282
    Event Type
    Other
    Date Received
    February 22, 2000
    Date of Event
    January 11, 2000
    Report Date
    February 22, 2000
    Manufacturer
    CARDIAC PACEMAKER INC, GUIDANT CORP. CARDIAC RHYTHM MGMT
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/3/00: THE DEVICE PERFORMED NORMALLY DURING TESTING AND WAS FOUND TO BE FUNCTIONING WITHIN SPEC. THE MEDWATCH FORM STATES THE DEVICE WAS PROPHYLACTICALLY REMOVED FOLLOWING A SAFETY ALERT THAT WAS ISSUED FOR SUCH DEVICES IMPLANTED SUBPECTORALLY. FOLLOW-UP WITH THE RPTR HAS FOUND THAT THE PT FULLY RECOVERED AND HAS EXPERIENCED NO FURTHER ADVERSE EVENTS. THE ICD WAS IMPLANTED IN 1998 AND REMOVED IN 2000. THE TOTAL IMPLANT DURATION WAS 16.3 MONTHS.

    Description of Event or Problem · 1

    SAFETY ALERT ISSUED FOR THOSE AICD'S IMPLANTED SUBPECTORALLY. PT PRESENTED FOR ELECTIVE AICD REPLACEMENT FOLLOWING MINI III SAFETY ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRAK MINI III AICD AUTOMATIC IMPLANTABLE DEFIBRILLATOR LWS CARDIAC PACEMAKER INC, GUIDANT CORP. CARDIAC RHYTHM MGMT 1782 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other