BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131507 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13817
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 4, 2014
    Report Date
    February 27, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PROVIDED FROM THE FIELD INDICATED THAT THE PATIENT WAS AGAIN SEEN, AND HIGH THRESHOLDS AND LOSS OF CAPTURE INVOLVING THE RV LEAD WERE OBSERVED. THE PATIENT REPORTED EXPERIENCING SOME DIZZY SPELLS, BUT THERE WERE NO PAUSES IN THEIR HEART RATE. A REVISION PROCEDURE WILL BE PLANNED WITHIN THE NEXT SEVERAL MONTHS AND FOR NOW THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT RECEIVED AN APPROPRIATE SHOCK WHICH LED TO THE RIGHT VENTRICULAR (RV) LEAD TO BEING MICRO-DISLODGED. AN INCREASE IN THRESHOLDS WAS ALSO NOTED. THE PATIENT¿S DEVICE WAS REPROGRAMMED, WHICH SLIGHTLY LOWERED THE PACING IMPEDANCE MEASUREMENTS OF THE RV LEAD. THE PATIENT WAS DISMISSED AND WILL CONTINUE TO BE MONITORED. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610628 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 0292