BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 1950827 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22765
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACING OUTPUT WAS REPROGRAMMED TO THE MAXIMUM SETTING AND A FOLLOW-UP APPOINTMENT WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE DUE TO A PACING FAILURE. INTERROGATION OF THE DEVICE INDICATED THE PACING FAILURE WAS LOSS OF CAPTURE CAUSED BY A RAPID RISE IN PACING THRESHOLD. THE PACING OUTPUT WAS INCREASED. HOWEVER, A FURTHER THRESHOLD INCREASE AND LOSS OF CAPTURE WAS NOTED SEVERAL DAYS LATER. NO FURTHER PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10128 DA 4285| 0447| 1130| 5281| MISMATCH