BEUDAMED
    FDA Adverse Event Death Summary report: N

    IIESTO 7 VR-T DX DF-1 US

    MDR report key: 4031510 · Received August 19, 2014

    Report

    Report Number
    1028232-2014-02826
    Event Type
    Death
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 1, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS FOUND "NON-RESPONSIVE IN RESIDENCE ON (B)(6) 2014." THE PATIENT HAD BEEN PREVIOUSLY DIAGNOSED WITH POST-PARTUM CARDIOMYOPATHY. THIS DEVICE WAS EXPLANTED ON (B)(6) 2014 DURING AN AUTOPSY. THE CORONER'S OFFICE STATED THE DEATH CERTIFICATE LISTS THE DATE OF DEATH AS (B)(6) 2014 DUE TO POST-PARTUM CARDIOMYOPATHY. THE CORONER'S OFFICE RETURNED THIS DEVICE FOR DISPOSAL AND HAS REPORTED NO COMPLAINTS WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499335 IIESTO 7 VR-T DX DF-1 US ICD LWS BIOTRONIK SE & CO. KG 383594

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death