BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910134 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15102
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INFORMATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP HIGH OUT OF RANGE PACING IMPEDANCES WERE NOTED AND LOSS OF CAPTURE WAS ALSO NOTED ON THIS RIGHT VENTRICULAR LEAD. A REVISION TOOK PLACE AND THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED AND REPLACED WHILE THE SHOCKING PORTION WILL CONTINUE TO BE USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17907 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4096| H199| 4517| 0148