BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860489 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15012
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    February 23, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGEST THESE PRODUCTS REMAINS IN-SERVICE. RESOLUTION WAS REQUESTED FROM THE FIELD. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGEST THESE PRODUCTS REMAINS IN-SERVICE. RESOLUTION ATTEMPTS WERE REQUESTED FROM THE FIELD. THE FIELD REPRESENTATIVE WAS HAD NOT BEEN NOTIFIED OF THE SITUATION AND COULD PROVIDE NO FURTHER DETAILS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A RISE IN IMPEDANCES ON THIS DEFIBRILLATION LEAD. AT IMPLANT, THE PACING IMPEDANCE WAS 800 OHMS AND LATER REPORTED AT 1783 OHMS. SHOCK LEAD IMPEDANCE WAS REPORTED AS 53 OHMS. THRESHOLDS WERE ALSO RISING. IT WAS THEN LATER REPORTED THAT THERE WAS ALLEGATION OF A POSSIBLE FRACTURE OF THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR T175| 0175