BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3100191 · Received May 8, 2013

    Report

    Report Number
    2124215-2013-07589
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    September 11, 2012
    Report Date
    January 9, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THE NOISE WAS OVERSENSED RESULTING IN NONSUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. PACING WAS NOT INHIBITED AS THE PATIENT HAS A NORMAL SINUS RHYTHM. HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE LATER NOTED. AN INVASIVE PROCEDURE WAS PERFORMED TO REVISE THE LEAD. THE DEVICE AND LEAD WERE SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200577 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4470| 624| T167| 0148