BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 4166488 · Received October 13, 2014

    Report

    Report Number
    2124215-2014-18225
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    May 7, 2014
    Report Date
    September 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS PACEMAKER EXHIBITED OVERSENSING IN BOTH RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNEL WHICH CAUSED INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR). ATRIAL PACING INHIBITION FOR 3.5 SECONDS AND VENTRICULAR PACING INHIBITION THAT LASTED FOR 3 SECONDS WERE NOTED. THE PATIENT REPORTED FEELING DIZZY. EXTENSIVE TROUBLESHOOTING WAS PERFORMED BUT WAS UNABLE TO INDUCE OVERSENSING ON BOTH LEADS. LEAD MEASUREMENTS WERE GOOD THOUGH SOME LOW P-WAVES WERE OBSERVED. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED OBSERVATIONS. PROGRAMMING WAS PERFORMED AND THERE HAVE BEEN NO RECENT EPISODES OF VENTRICULAR INHIBITION THOUGH THERE WERE NEW ATR EPISODES SHOWING ATRIAL INHIBITION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646129 SELUTE IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 5524M| 4285| 1291| K063| 4053| 4058| 1270| 1230