BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3790246 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-09591
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. REQUESTS TO RETURN THIS LEAD HAVE BEEN MADE. HOWEVER, THERE WAS NO CONFIRMATIONS THAT LEAD HAD BEEN RETURNED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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 THIS RIGHT VENTRICULAR (RV) LEAD GOT GORE COVERING AND CONDUCTOR DAMAGE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DAMAGE WAS NOTICED AFTER THE LEAD WAS REMOVED AND REATTEMPTED FOR REPOSITIONING. THIS LV LEAD WAS NEVER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS AN ATTEMPTED IMPLANT, AND UPON REMOVAL FROM THE PATIENT, THE LEAD SUSTAINED DAMAGE TO THE GORE COVERING AND THE CONDUCTOR WAS OBSERVED TO BE FRACTURED. THIS LEAD WAS ATTEMPTED, BUT NOT IMPLANTED. ANOTHER RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266346 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 166 MO Hospitalization| L| R 0292| E160| 0295