BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913369 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00477
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACE/SENSE PORTION OF THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING WHICH RESULTED IN PACING INHIBITION. NO ASYSTOLE GREATER THAN TWO SECONDS WAS OBSERVED. THE LEAD WAS NOTED TO BE FRACTURED AND SURGICAL INTERVENTION WAS PERFORMED. THE PACE/SENSE PORTION OF THIS RV LEAD WAS SURGICALLY ABANDONED, AND THE HIGH VOLTAGE PORTION REMAINS IN SERVICE. ANOTHER RV PACE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20759 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 1860| MISMATCH| H210| 4469| 0158