BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910590 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16077
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 AT A RECENT FOLLOW UP, CONSISTENT NOISE WAS NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD AND A COMPETITOR RIGHT ATRIAL LEAD. THE NOISE LED TO NUMEROUS INAPPROPRIATE ANTI TACHYCARDIA PACING EPISODES, HOWEVER, NO INAPPROPRIATE SHOCK THERAPIES. ADDITIONALLY, DECREASED PACING IMPEDANCES TO LEVELS BELOW 200 OHMS WAS ALSO NOTED ON THE RV LEAD. A PROCEDURE WAS PERFORMED TO ASSESS THE LEAD, AND IT WAS DETERMINED THE ROOT CAUSE OF THE ISSUE WAS SUBCLAVIAN CRUSH, RESULTING IN BOTH A LEAD CONDUCTOR FRACTURE AND INSULATION ISSUES. BOTH THE RV AND COMPETITOR (B)(4) LEADS WERE SURGICALLY ABANDONED AND REPLACED DUE TO THE ISSUE. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18746 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0148| 4512| 5568| 4087| F110| H155