BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEGO S 60

    MDR report key: 6120859 · Received November 22, 2016

    Report

    Report Number
    1028232-2016-04664
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    September 30, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    WE WERE NOTIFIED BY THE PATIENTS FAMILY THAT THIS PATIENT EXPIRED ONE WEEK AFTER THE ICD SYSTEM WAS IMPLANTED. THE FAMILY NOTED THAT THE ICD DELIVERED 3 SHOCKS THE DAY AFTER IMPLANT AND THAT THERAPY WAS TURNED OFF 3 DAYS AFTER SURGERY BECAUSE THE MEDICATION THE PATIENT WAS ON AND THE DEVICE WERE TOO MUCH FOR THE PATIENTS BODY. THE FAMILY BELIEVES THAT THE ICD WAS EXPLANTED BEFORE THE PATIENT WAS CREMATED. THE ICD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773364 PROTEGO S 60 ICD LEAD NVY BIOTRONIK SE & CO. KG 379970

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death