BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT

    MDR report key: 6070543 · Received November 1, 2016

    Report

    Report Number
    2649622-2016-13829
    Event Type
    Death
    Date Received
    November 1, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DDBB1D1 ICD, IMPLANTED: (B)(6) 2016. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. IT WAS ALSO REPORTED THE MONITORED EPISODES WERE FOUND TO FALL IN AND OUT OF THE DETECTION ZONES AND THERE WERE VENTRICULAR TACHYCARDIA (VT) NON SUSTAINED EPISODES AND HIGH RATE NON SUSTAINED EPISODES. ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS LEARNED THAT FIVE DAYS PRIOR THE DEVICE AND LEAD WERE INTERROGATED AND FOUND TO BE FUNCTIONING NORMALLY. NO OTHER INFORMATION WAS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719734 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694265

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death 4592-53 LEAD