BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211088 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08321
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    November 1, 2012
    Report Date
    April 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE RETURN OF THE PRODUCT IS NOT EXPECTED AT THIS TIME. 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 THIS IMPLANTABLE DEFIBRILLATION EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. REVIEW OF STORED DEVICE MEMORY REVEALED THAT THE OUT OF RANGE MEASUREMENTS BEGAN APPROXIMATELY FIVE MONTHS AGO. ADDITIONALLY, THE LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN PACING INHIBITION FOR GREATER THAN 2 SECONDS. THE PATIENT WAS PACEMAKER DEPENDENT. A LEAD FRACTURE WAS SUSPECTED. THE LOCAL FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO INQUIRE ABOUT ACTIVATING THE OFF ELECTROCAUTERY FEATURE TO PREVENT PACING INHIBITION. TS DISCUSSED THAT WAS OFF LABEL USE. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311076 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R H217| 0185| 4543