BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEXA PROMRI DF-1 S DX 65/15

    MDR report key: 13154821 · Received January 4, 2022

    Report

    Report Number
    1028232-2021-07019
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 27, 2021
    Report Date
    December 27, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    UDI-DI
    04035479151027
    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.

    Additional Manufacturer Narrative · 0

    (B)(6) 2022 - PHYSICIAN DECIDED TO CAP THIS LEAD DUE TO NOISE. ONCE THE NEW LEAD WAS CONNECTED TO THE CHRONIC ICD THERE WAS STILL NOISE SO THE ICD WAS REPLACED AS WELL. 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

    HOME MONITORING REPORTS SHOCK TO DOUBLE COUNTING (NML DEVICE FUNCTION) LEAD EVALUATION ON HOME MONITORING SHOWS INCREASE IN PACING THRESHOLD SINCE (B)(6). LEAD IMPEDANCE AND SHOCK IMPEDANCE UNCHANGED. MULTIPLE IEGMS SHOW MINIMAL NOISE OF EMI VS LEAD ISSUE. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

    Description of Event or Problem · 0

    HOME MONITORING REPORTS SHOCK TO DOUBLE COUNTING ( NML DEVICE FUNCTION). LEAD EVALUATION ON HOME MONITORING SHOWS INCREASE IN PACING THRESHOLD SINCE AUGUST. LEAD IMPEDANCE AND SHOCK IMPEDANCE UNCHANGED. MULTIPLE IEGMS SHOW MINIMAL NOISE OF EMI VS LEAD ISSUE. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159080 PLEXA PROMRI DF-1 S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 414005 04035479151027

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male