BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053112 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04125
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT DUE TO GREATER THAN 200 OHM SHOCK LEAD IMPEDANCE MEASUREMENTS, A LEAD EXTRACTION WAS PERFORMED. DURING THE REVISION PROCEDURE, A VENOGRAM SHOWED VENOUS OCCLUSION. IT WAS NOTED UPON INSPECTION THAT THE TERMINAL END FOR THE DISTAL COIL WAS NOT FASTENED INTO THE HEADER, THE SET SCREW WAS LOOSE AND THE LEAD PULLED OUT EASILY. THE RV LEAD WAS RE-SEATED INTO THE HEADER WITH SUCCESSFUL DEFIBRILLATION THRESHOLD TESTING WITH NORMAL SHOCK LEAD IMPEDANCE MEASUREMENTS (31 OHMS). THE LEAD REMAINED IN THE TRIAD CONFIGURATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INCREASED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS WERE OBSERVED WITH THIS DEVICE SYSTEM. TECHNICAL SERVICES DISCUSSED EVALUATION RECOMMENDATIONS. SEVERAL PAINLESS SHOCK IMPEDANCE TESTS WERE PERFORMED WITH GREATER THAN 125 OHMS MEASURED. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING WAS PERFORMED AND THE DEVICE CONVERTED SUCCESSFULLY AT 21 J. THE PAINLESS TEST WAS AGAIN PERFORMED, RESULTING IN IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE LIMITS. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE DEVICE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R N119| 4543| 5076| H177| 1853| 0158