BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953842 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24097
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    July 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A 1.1 JOULE SHOCK WAS DELIVERED TO THE PATIENT AND THE RESULTING SHOCK IMPEDANCES WERE 81 OHMS. A 41 JOULE SHOCK WAS ALSO DELIVERED, WITH A SHOCK IMPEDANCE OF 79 OHMS, AND DEFIBRILLATION THRESHOLD (DFT) TESTING CONVERTED THE PATIENT WITH SHOCK IMPEDANCES OF 80 OHMS. IT WAS NOTED THAT THE PHYSICIAN WAS CONFIDENT THAT THE SYSTEM WAS OKAY AND SUSPECTS THE VARIABILITY MAY BE IMPACTED BY THE PATIENT CONDITION, AS THE PATIENT'S POCKET SEEMED LARGE AND THE DEVICE MOVED AROUND MORE THAN EXPECTED; HOWEVER, THE PHYSICIAN WAS NOTED TO NOT BE CONCERNED ENOUGH ABOUT THE MOVEMENT TO REVISE THE POCKET. THUS THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS TRANSVENOUS DEFIBRILLATION LEAD DUE TO HIGH SHOCK IMPEDANCES. IT WAS NOTED THAT SHOCK IMPEDANCES WERE APPROXIMATELY 80 OHMS AT IMPLANT, BUT HAVE BEEN STEADILY INCREASING. TECHNICAL SERVICES (TS) DISCUSSED THE HIGHER IMPEDANCE AT IMPLANT COULD BE DUE TO THE SINGLE COIL LEAD. TS REVIEWED SOME EPISODES AND NOTED POSSIBLE FARFIELD OVERSENSING THAT WAS NOT SENSED BY THE DEVICE. TS DISCUSSED POSSIBLE CAUSES FOR THE HIGH SHOCK IMPEDANCES AND TROUBLESHOOTING OPTIONS. THE PATIENT WAS BROUGHT TO THEIR CLINIC FOR LEAD TESTING AND ALL SHOCK IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 4470| 0181| N119| 4592