BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851839 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14384
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    October 10, 2002
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    GUIDANT (NOW BOSTON SCIENTIFIC CRM) RECEIVED INFORMATION THAT THIS IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED HIGHER THAN EXPECTED PACING THRESHOLD MEASUREMENTS, TWO WEEKS POST IMPLANT. THERE WERE NO CHANGES MADE TO THE LEAD SYSTEM AT THAT TIME, THE PHYSICIAN ELECTED SCHEDULING THE PATIENT FOR MORE FREQUENT FOLLOW-UPS. ADDITIONAL INFORMATION WAS PROVIDED THAT APPROXIMATELY EIGHT YEARS LATER, THE LEAD EXHIBITED HIGH PACING THRESHOLDS, AS WELL AS LOSS OF RIGHT VENTRICULAR (RV) CAPTURE. THE LEAD WAS THEREFORE SURGICALLY CAPPED AND REPLACED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 1861| 4470| 0148