BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041669 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01444
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 15, 2011
    Report Date
    December 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BROUGHT INTO CLINIC AND HIGH PACING IMPEDANCE MEASUREMENTS WERE STILL OBSERVED. ALL OTHER LEAD DIAGNOSTICS WERE ACCEPTABLE AND THERE WAS NO EVIDENCE OF NOISE. TECHNICAL SERVICES DISCUSSED CONTINUED MONITORING OR REPLACING THE RATE/SENSE PORTION OF THE LEAD. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT RECENTLY UNDERWENT A ROUTINE DEVICE CHANGE OUT PROCEDURE. SHORTLY AFTER IMPLANT, THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD AND THE NEWLY IMPLANTED CRT-D EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE ALERT WAS ISSUED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 4549| 4469| H219| 0147| 4518