BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR D

    MDR report key: 17585887 · Received August 21, 2023

    Report

    Report Number
    1028232-2023-04158
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    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 AND NO FURTHER INFORMATION IS EXPECTED. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS EXTERNAL PACEMAKER WAS CONNECTED TO A PACING DEPENDENT PATIENT. WHEN THE BATTERY NEEDED TO BE CHANGED DUE TO LOW CHARGE THE EXPECTED 30 SECONDS OF SAFETY CHARGE WERE NOT PROVIDED BY THE DEVICE. THUS THE PATIENT REQUIRED RESUSCITATION. AFTER INSERTING THE NEW BATTERY, THE PATIENT RECOVERED WITHOUT FURTHER SIDE EFFECTS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459233 REOCOR D EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization