BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910086 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15312
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 16, 2012
    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

    RESOLUTION HAS BEEN REQUESTED FROM THE FIELD, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS EVENT WILL BE UPDATED UPON FURTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT NO FURTHER TESTING WAS DONE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS BROUGHT IN AND A COMMANDED 2 JOULE SHOCK WAS DELIVERED WHICH REPORTED A 75 OHMS SHOCK IMPEDANCE MEASUREMENT. A 41 JOULE SHOCK WAS ALSO DELIVERED WHICH REPORTED A 76 OHMS SHOCK IMPEDANCE MEASUREMENT. NO ADDITIONAL INTERVENTION PLANNED TO BE PERFORMED AND THE ISSUE PLANNED TO BE MONITORED . NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED A THRESHOLD AT IMPLANT OF 0.9 AND A CURRENT INCREASE TO 1.3 ON THIS RIGHT VENTRICULAR (RV) LEAD. SHOCK IMPEDANCES WERE STABLE AROUND 64 OHMS AND HAD INCREASED TO 87 OHMS IN TRIAD. COIL TO CAN WAS 100 OHMS AND COIL TO COIL WAS GREATER THAN 125 OHMS. THIS PATIENT HAD DEFIBRILLATION THRESHOLD TESTING AT IMPLANT, SUCCESSFULLY CONVERTED AT 26 JOULES, BUT SINCE HAD NOT RECEIVED A SHOCK FROM THE DEVICE. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING AND PERFORMANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19011 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| R 4470| 0185| 2187| H170| 4549| N119| H177