BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2914336 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00669
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO OUT OF RANGE PACING IMPEDANCES. THERE WAS NO VISUAL EVIDENCE OF AN INSULATION ISSUE OR A LEAD FRACTURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT THIS PATIENT WAS SCHEDULED FOR A FOLLOW UP. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE PACING IMPEDANCES ON THE RIGHT VENTRICULAR LEAD. 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
    21177 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R