BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA MEDICAL PACE 203

    MDR report key: 23850341 · Received December 19, 2025

    Report

    Report Number
    9681449-2025-00004
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 18, 2025
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    UDI-DI
    04260451441128
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION ON 2025-12-09. DURING INITIAL VISUAL INSPECTION AND FUNCTIONAL TEST NO NONCONFORMITIES COULD BE IDENTIFIED WHICH WOULD EXPLAIN THE REPORTED BEHAVIOR. THE PACEMAKER WORKED ACCORDING TO ITS SPECIFICATION. ALSO, THE TEST RECORDS OF THE FINAL TEST DURING PRODUCTION HAS BEEN REVIEWED WITHOUT ANY FINDINGS. THE PACEMAKER PASSED ALL TESTS DURING PRODUCTION INCL. THE FINAL COMPETE SAFETY AND FUNCTIONAL TEST. SINCE THE REPORTED BEHAVIOR COULD NOT BE REPRODUCED DURING INITIAL EVALUATION, THE DEVICE WAS SUBJECTED TO A LONG-TERM TEST. AN ATTEMPT WAS MADE TO PROVOKE THE DESCRIBED DEFECT OVER A PERIOD OF 160 HOURS UNDER THERMAL CYCLING IN A CLIMATE CHAMBER. THE PACEMAKER RAN WITHOUT INTERRUPTIONS AND SHOWED NO SIGNS OF A DEFECT. IT CANNOT BE EXCLUDED THAT A DEPLETED BATTERY CAUSED THE SHUTDOWN WHEN THE LOW BATTERY ALARM WAS NOT RECOGNIZED BY THE USER. ALSO, A HIDDEN DEFECT ON THE PRINTED CIRCUIT BOARDS CAN NOT BE EXCLUDED. FOR THIS REASON, THE REPLACE OF THE ELECTRONIC BOARDS WILL BE SUGGESTED TO THE CUSTOMER AS PRECAUTION MEASURE.

    Description of Event or Problem · 0

    WE HAVE RECEIVED THE FOLLOWING REPORT FROM THE (B)(6) - SWEDISH MEDICAL PRODUCT AGENCY: THE DEVICE TURNED OFF SPONTANEOUSLY AND COULD NOT BE RESTARTED UNTIL IT RECEIVED A NEW BATTERY. ON TWO CHECKS DURING THE HOUR BEFORE, THE BATTERY INDICATOR SHOWED THAT THE BATTERY WAS FULL. THE DEVICE IS SUPPOSED TO ALARM WHEN THE BATTERY IS EMPTY AND IS THEN POWERED BY A BACK-UP CAPACITOR. IN THE CURRENT CASE, THE DEVICE HAS NEITHER ALARMED WHEN THE BATTERY WAS LOW NOR WHEN THE BATTERY WAS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423932 OSYPKA MEDICAL PACE 203 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203 04260451441128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other