BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 2944593 · Received February 5, 2013

    Report

    Report Number
    2124215-2013-01746
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    August 15, 2012
    Report Date
    April 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY DUE TO MULTI-SYSTEM ATROPHY. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE OR THE LEADS RELATED TO THE PATIENT'S DEATH. IT WAS NOT KNOWN IF THE DEVICE AND LEADS WOULD BE RETURNED AS THE FIELD REPRESENTATIVE DID NOT KNOW THE DETAILS OF THE FUNERAL ARRANGEMENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ALONG WITH DECREASED PACING IMPEDANCES OCCASIONALLY LESS THAN 200 OHMS. THE PACING THRESHOLDS ARE STABLE. THE PATIENT HAS A COMPLEX MEDICAL HISTORY AND THE PHYSICIAN HAS PROGRAMMED THE PACEMAKER TO PACE IN THE VENTRICLE AT VOOR AS THE PATIENT IS PACER DEPENDENT. THE PATIENT IS BEING MONITORED EVERY FOUR TO SIX WEEKS, WHICH CONSIST OF OFFICE VISITS FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48898 SELUTE IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR S606| 4244| 4137| 4285| 1280| 1290