BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170888 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10080
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DETECTED INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. ADDITIONALLY, MULTIPLE DIVERTED EPISODES AND THERAPY EPISODES WERE OBSERVED, LIKELY A RESULT OF NOISE. COMMANDED SHOCKS WERE DELIVERED ON THE DEVICE SYSTEM, WHICH CONFIRMED THE OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED, SO FURTHER TESTING WAS NOT PERFORMED. CAPTURE WAS OBSERVED AT CURRENT OUTPUT SETTING AND TACHY THERAPY REMAINED PROGRAMMED ON. THE PATIENT IMPLANTED WITH THIS DEVICE WAS TO BE TRANSPORTED TO THE HOSPITAL FOR FURTHER EVALUATION. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE PACE/SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    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 64 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)