BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212500 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08553
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DURING A ROUTINE DEVICE UPGRADE PROCEDURE, THE SENSING DECREASED ON THE RIGHT VENTRICULAR (RV) LEAD. AFTER THE SENSITIVITY WAS REPROGRAMMED, VENTRICULAR FIBRILLATION (VF) COULD NOT BE DETECTED. AS A RESULT, A NEW PACE/SENSE LEAD WAS IMPLANTED. WHEN A 21J SHOCK WAS DELIVERED, THE VR WAS NOT ELIMINATED. ADDITIONALLY, AN ERROR MESSAGE APPEARED STATING THE DEVICE BATTERY WAS DEPLETED. A SECOND DEVICE (P143/104368) WITH THE SAME RV LEAD WAS IMPLANTED AND THE ERROR MESSAGE PERSISTED. THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED. A THIRD DEVICE WAS IMPLANTED WITH A NEW RV LEAD AND THE DEVICE AND LEAD BOTH OPERATED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313044 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1