BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2920888 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01131
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO X-RAY WAS TAKEN AND THE PATIENT WAS SCHEDULED FOR ANOTHER FOLLOW-UP VISIT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS OVERSENSING OF THE ATRIUM ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE OVERSENSING DID LEAD TO PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED AN X-RAY TO DETERMINE PLACEMENT OF THE RV LEAD. POSSIBLE INTERFERENCE FROM THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS ALSO DISCUSSED. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN RESOLUTION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25945 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR 0185| E102