BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSYPKA PACE 203H

    MDR report key: 12720641 · Received October 29, 2021

    Report

    Report Number
    9681449-2021-00002
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 29, 2021
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PACEMAKER WITH S/N (B)(4) HAS BEEN RETURNED TO OUR (B)(4) DISTRIBUTION PARTNER WHO FORWARDED IT TO OSYPKA MEDICAL. WE RECEIVED IT ON 21-OCT-2021. THE INITIAL INVESTIGATIONS DID NOT SHOW EVIDENCE OF ANY MALFUNCTION OF THE DEVICE. SOME MECHANICAL DAMAGES HAVE BEEN FOUND LIKE A CRACKED TOP HOUSING PART AND BATTERY RELEASE BUTTON. BUT NONE OF THESE DAMAGES COULD CAUSE THE MALFUNCTION, WHICH WOULD EXPLAIN THE REPORTED BEHAVIOR. THE BATTERY DOOR WAS FOUND A BID STIFF DUE TO SOME CONTAMINATION IN THE HINGE OF THE BATTERY DOOR. BUT THE LOCK/UNLOCK MECHANISM OF THE BATTERY COMPARTMENT WORKED WELL (AS CONFIRMED BY THE HOSPITAL TECHNICIAN AS WELL). THE STIFFNESS OF THE BATTERY DOOR WOULD EXPLAIN THAT THE BATTERY HAD ELECTRICAL CONTACT AND THE DEVICE WORKED EVEN WITH BATTERY DOOR UNLOCKED AS REPORTED BY THE HOSPITAL. THE PACEMAKER HAS AN ACOUSTIC LOW BATTERY ALARM. WHENEVER THE BATTERY WOULD HAVE A LOOSE ELECTRICAL CONTACT TO THE BATTERY TERMINALS, THE ALARM WOULD ACTIVATE, WHICH WAS EVIDENT IN THE EVALUATION. THE PACEMAKER ALSO HAS AN INTERNAL ENERGY STORAGE WHICH ALLOWS THE OPERATION WITHOUT BATTERY CONNECTED FOR AT LEAST 30 SEC. THIS FEATURE ALLOWS BATTERY EXCHANGE DURING OPERATIONS. ON THE ACTUAL DEVICE WE TESTED THE BATTERY SURVEILLANCE TIME WITH 156 SEC. THAT MEANS THE PACEMAKER MAINTAINS PACING AND PERMANENT ACOUSTIC ALARM FOR THIS PERIOD. ALSO THE SUSPECTED 9 VOLT BATTERY NX POWER TECH, 6LR61 ALKALINE WOULD NOT EXPLAIN THE REPORTED BEHAVIOR BECAUSE THE LOW VOLTAGE WOULD HAVE BEEN INDICATED BY THE LOW BATTERY ALARM AND RECOGNIZED BY THE USER. BUT THE HOSPITAL REPORTED THAT THERE WAS NO ACOUSTIC ALARM WHEN THE INCIDENT HAPPENED. THE HOSPITAL STAFF ALSO MENTIONED THAT THE PATIENT ARREST AND THE DOOR OPENING COULD BE COINCIDENTAL. A POSSIBLE REASON FOR THE LOSS OF PACING COULD WOULD BE LOSS OF CAPTURE, I.E. THE ADJUSTED OUTPUT AMPLITUDE AND PULSE WIDTH DOES NOT PROVIDE ENOUGH ENERGY FOR DEPOLARIZATION OF THE HEART MUSCLE CELLS AND EFFECTIVE PACING. THE CAPTURE THRESHOLD MAY CHANGE DURING PATIENT TREATMENT. WITH FURTHER EVALUATION THE DEVICE UNDERWENT A LONG TIME PACING TEST IN A TEMPERATURE CHAMBER FOR 96H WITH CYCLING TEMPERATURES BETWEEN 35°C AND 15°C IN ORDER TO FIND ANY HIDDEN INTERMITTENT DEFECTS. THE TEST WAS PASSED WITHOUT ANY FINDINGS. THE PACEMAKER WORKED ACCORDING TO ITS SPECIFICATION. THE ROOT CAUSE OF THE REPORTED INCIDENT REMAINS UNCLEAR.

    Description of Event or Problem · 0

    THE FOLLOWING HAVE BEEN REPORTED BY THE HOSPITAL: (1) THE PATIENT WAS BEING PACED DDD; I NOTICED THE BATTERY COVER WASN'T QUITE CLOSED. I HAD MY FINGER OVER IT TRYING TO CLOSE IT WHEN THE PACING BOX VENTRICULAR PACING FAILED AND THE PATIENT LOST OUTPUT. (2) CARDIAC ARREST - PATIENT RECOVERED. ADDITIONAL INFORMATION BY CLINICAL ENGINEERING: CASE FAIRLY TIDY, SIGNS OF DAMAGE TO BOTTOM FRONT LHS AND RHS FRONT CASING IMPACT. FUNCTIONAL CHECK OF BATTERY COVER - BATTERY COVER CLOSES BUT DOES NOT FEEL POSITIVE WHEN CLOSING. CLOSED EVERY TIME - UNABLE TO REPLICATE FAULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617280 OSYPKA PACE 203H EXTERNAL PULSE GENERATOR DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening