BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLEXA PROMRI S DX 65/15

    MDR report key: 12306417 · Received August 11, 2021

    Report

    Report Number
    1028232-2021-04497
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    July 26, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    UDI-DI
    04035479158781
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 1

    HOME MONITORING TRANSMISSIONS SHOWED SHOCK IMPEDANCE GREATER THAN 150 OHMS. THE OFFICE TRIED TO CONTACT PATIENT BUT WAS UNABLE TO REACH HIM. THEY CONTACTED LAW ENFORCEMENT TO DO A WELLNESS CHECK. PATIENT WAS DECEASED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205562 PLEXA PROMRI S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 436909 04035479158781

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death