BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173340 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10634
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS SUSPECTED VENTRICULAR UNDERSENSING AND LOSS OF CAPTURE. EPISODES WERE REVIEWED AND IT APPEARED THAT THE SENSOR PACING WAS COMPETING WITH THE ARRHYTHMIA. THEREFORE, IT WAS DIFFICULT TO TELL IF THERE WAS UNDERSENSING OR CAPTURE. IT WAS DISCUSSED THAT THERE COULD BE UNDERSENSING DUE TO THE BLANKING PERIOD AFTER THE PACE AND THAT PACING MAY NOT TO CAPTURE IF PACING AFTER THE INTRINSIC BEAT. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening 0184| 4525| H215| 4469