BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913113 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16742
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED, THEREFORE, ANALYSIS CANNOT BE PERFORMED IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION REVEALED THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE RESULTING IN OVERSENSING. IN ADDITION, IMPEDANCE MEASUREMENTS WERE LOW OUT OF RANGE. NO INAPPROPRIATE THERAPY HAD BEEN DELIVERED AS A RESULT OF THIS ISSUE. THE ARRHYTHMIA LOGBOOK REVEALED THERE HAD BEEN ONE DIVERTED SHOCK EPISODE. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED AND REPLACED SUCCESSFULLY. POST LEAD REPLACEMENT NORMAL MEASUREMENTS WERE OBTAINED. DURING THE REMOVAL PROCEDURE, THIS LEAD WAS DAMAGED AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19634 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R