BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR S

    MDR report key: 23127057 · Received September 23, 2025

    Report

    Report Number
    1028232-2025-04641
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 17, 2025
    Report Date
    January 19, 2026
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE EXTERNAL PACEMAKER REOCOR WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. WITHIN THIS ANALYSIS THE DEVICE WAS VISUALLY, MECHANICALLY AND FUNCTIONALLY INSPECTED. THE VISUAL AND MECHANICAL ANALYSIS REVEALED THAT THE MODE DIAL OF THE EXTERNAL PACEMAKER WAS DIFFICULT TO TURN. IN ADDITION, THE INDIFF. + CONNECTOR WAS SLIGHTLY VISUALLY IMPAIRED. APART FROM THAT, THE DEVICE WAS IN GOOD VISUAL AND MECHANICAL CONDITION. DURING FUNCTIONAL ANALYSIS THE OBSERVATION REGARDING A STIMULATION FAILURE COULD NOT BE CONFIRMED. THE EXTERNAL PACEMAKER WORKED AS EXPECTED. THE ABILITY OF THE DEVICE TO SENSE CARDIAC SIGNALS AS WELL AS TO DELIVER ANTI-BRADYCARDIA THERAPY WAS TESTED AND PROVED TO BE FULLY FUNCTIONAL. DURING A LONG-TERM STIMULATION TEST, NO IRREGULARITIES WERE DETECTED WITH VARIOUS STIMULATION PARAMETERS WERE TAKEN INTO ACCOUNT. THE DEVICE OPERATED IN ACCORDANCE WITH THE SPECIFICATIONS AND NO PACING FAILURE OF THE PACEMAKER COULD BE DETECTED. DUE TO THE SLIGHT MECHANICAL AND VISUAL IMPAIRMENTS, THE UPPER HOUSING PART AS WELL AS THE CONNECTION SOCKETS WERE REPLACED, AFTERWARDS ALL DEVICE FUNCTIONS WERE IN SPECIFICATION. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES.

    Description of Event or Problem · 0

    ON (B)(6) AN IMPLANTATION WAS PERFORMED USING THE REOCOR. LEAD IMPLANTATION WAS COMPLETED, HOWEVER, PACING FAILURE OCCURRED. REPLACEMENT OF THE PATIENT CABLE DID NOT RESOLVE THE ISSUE. SUBSEQUENTLY, THE EXTERNAL PACEMAKER WAS REPLACED WITH A COMPETITORS DEVICE, AFTER WHICH THE PACING FAILURE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579600 REOCOR S EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization