BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2905470 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13492
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 3, 2012
    Report Date
    October 16, 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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    WHEN THE REVISION PROCEDURE HAS BEEN PERFORMED, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE ON THE PACE/SENSE ELECTROGRAM CHANNEL AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THRESHOLD TESTING COULD NOT BE PERFORMED DUE TO THE NOISE. IT WAS THOUGHT THIS LEAD WAS FRACTURED. THE NOISE WAS REPRODUCED BY MANIPULATING THE SUBCLAVIULAR AREA. NO NOISE WAS REPRODUCED DURING PECTORAL MYOPOTENTIALS. A CHEST X-RAY DID NOT REVEAL AN OBVIOUS FRACTURE. REVIEW OF THE ARRHYTHMIA LOG BOOK REVEALED RECENT SUSTAINED NOISE EPISODES HAD OCCURRED WITHIN THE PAST FEW DAYS. THE PATIENT WITH THIS LEAD IS NOT PACEMAKER DEPENDENT. THE THERAPY WAS PROGRAMMED OFF AND THE PATIENT REMAINS HOSPITALIZED UNTIL A REVISION PROCEDURE IS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY REMOVED. THE LEAD WAS CUT DURING THE PROCEDURE AND NO RETURN IS INTENDED. AT THIS TIME, THERE HAS BEEN NO REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10657 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0171

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0171| T175