BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEXA PROMRI DF-1 SD 65/18

    MDR report key: 13871744 · Received March 24, 2022

    Report

    Report Number
    1028232-2022-01412
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 14, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    UDI-DI
    04035479151003
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 · 0

    SCV COIL SHOCK IMPEDANCE READING AT 190OHMS. CLINICIAN TO PROGRAM SO RV COIL ONLY. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726904 PLEXA PROMRI DF-1 SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 414001 04035479151003

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization