BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S DX 65/15

    MDR report key: 4031514 · Received August 19, 2014

    Report

    Report Number
    1028232-2014-02828
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    June 13, 2024
    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 HEALTH CARE PROFESSIONAL
    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. PER THE CORONER'S OFFICE, 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
    499336 LINOX SMART S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Death