BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161213 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07104
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN X-RAY WAS PERFORMED AND NO INDICATIION OF A LEAD FRACTURE WAS FOUND. AT THIS TIME THE PATIENT WILL CONTINUE TO BE MONITORED AS THE EJECTION FRACTION HAS IMPROVED AND THE DEVICE MAY NOT BE REPLACED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD HAD RECEIVED MULTIPLE SHOCKS. UPON INTERROGATION OF THE DEVICE, RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS WERE OBSERVED. SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS WERE ALSO NOTED. IT WAS REPORTED THAT THE RV ELECTROGRAM APPEARED FLAT AND LOSS OF CAPTURE WAS OBSERVED. NOISE WAS REPRODUCED IN CLINIC ON BOTH THE RATE/SENSE AND SHOCK CHANNELS. A CHEST X-RAY WAS PLANNED FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 0185| E030| 4471