BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2055615 · Received April 14, 2011

    Report

    Report Number
    2124215-2011-04850
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IT IS SUSPECTED THAT THE DEVICE WAS BURIED WITH THE PATIENT. IF THE DEVICE IS RETURNED THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. A PROCEDURE TOOK PLACE AND THE CONNECTIONS WERE VERIFIED ENSURING THE TERMINAL PIN WAS PAST THE CONNECTOR BLOCK. ONE DAY LATER, THE OUT OF RANGE MEASUREMENTS REAPPEARED. AFTER FURTHER EVALUATION, IT WAS COMMUNICATED THIS PATIENT HAD A CORONARY ARTERY BYPASS GRAFT PROCEDURE FIVE DAYS PRIOR TO THE CRT-D IMPLANT. THE PATIENT WAS ALSO VERY SWOLLEN DUE TO AIR IN THEIR CHEST FROM THE CHEST TUBE BEING REMOVED TOO SOON. IT WAS CONCLUDED THAT THE AIR IN THE PATIENT'S CHEST WAS HAVING AN AFFECT ON THE IMPEDANCE MEASUREMENTS. A DISK EVALUATION WAS SENT IN FOR ANALYSIS. FOUR DAILY SHOCK LEAD IMPEDANCE MEASUREMENTS RECORDED WERE 241, 101, 84, AND 60 OHMS. THE MOST RECENT MANUAL SHOCK LEAD IMPEDANCE VALUE WAS 59 OHMS. NO FURTHER ACTION PLANNED TO BE TAKEN AS THE PATIENT'S CONDITION AFFECTING THE SHOCK LEAD IMPEDANCE HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R 0180| N119| 4965| 4469