BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3070427 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06511
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A REMOTE MONITORING SYSTEM THAT DETECTED AN OUT OF RANGE LOW SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS UNDERGOING A CATH PROCEDURE AT THE TIME THE OUT OF RANGE MEASUREMENTS WERE OBSERVED. IT WAS DISCUSSED WITH A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THAT THE PATIENT BE BROUGHT IN FOR LEAD EVALUATION TO ENSURE LEAD INTEGRITY. A REQUEST FOR STATUS OF THE LEAD HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172346 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR N119| 5076| 0185| 4542