BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860689 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15160
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    June 28, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION SUGGESTS THAT THIS LEAD REMAINS IN SERVICE WITH THE COMPETITIVE DEVICE, AND THAT THE PHYSICIAN IS MONITORING THE LEAD AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT RV IMPEDANCES OF GREATER THAN 3,000 OHMS WERE AGAIN OBSERVED. NOISE WAS ALSO NOTED ON THE RV CHANNEL WITH PATIENT BODY MOVEMENT. IT WAS NOTED THAT A LEAD FRACTURE WAS SUSPECTED AND THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN PACING IMPEDANCE MEASUREMENTS FROM 340 OHMS TO GREATER THAN 3000 OHMS. RV CHANNEL SENSING AND CAPTURE REMAIN ACCEPTABLE, AND NO NOISE HAS BEEN OBSERVED WITH ISOMETRIC TESTING. OF NOTE, THE PATIENT'S DEVICE IS A COMPETITIVE PRODUCT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION.

    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 61 YR MISMATCH| 1852| T135| 0185