BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040842 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02484
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD AND A COMPETITOR'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PAUSES OF FIVE AND NINE SECONDS. REVIEW OF STORED ELECTROGRAMS (EGM) FROM THE DEVICE SHOWED A NONSUSTAINED EVENT WHICH WAS FINE NOISE WITH OVERSENSING AND PACING INHIBITION. OTHER LEAD DIAGNOSTICS WERE NOTED TO BE NORMAL. IT IS UNKNOWN WHAT THE PATIENT'S SYMPTOMS WERE, IF ANY, DURING THESE EPISODES. SURGICAL INTERVENTION WAS PERFORMED, AND AT THE PROCEDURE THE PHYSICIAN WAS UNABLE TO REPRODUCE THE NOISE, BUT DUE TO THE PATIENT'S PACEMAKER DEPENDENCY CHOSE TO SURGICALLY ABANDON THIS LEAD. A NEW RV LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143446 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 0157| 4470| A155| MISMATCH