BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSYPKA PACE 203H

    MDR report key: 20864027 · Received December 6, 2024

    Report

    Report Number
    9681449-2024-00004
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 20, 2025
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Removal / Correction Number
    Z-2443-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OSYPKA MEDICAL RECEIVED MORE DETAILS ABOUT THE INCIDENT ON (B)(6)2025: ACCORDING TO THIS IT IS STILL NOT CLEAR IF THE DEVICE SUDDENLY POWERED OFF OR STOPPED PACING WITH AN ERROR MESSAGE. EVEN AN HUMAN ERROR WAS NOT EXCLUDED. WE DID FULL FUNCTIONAL AND SAFETY TEST (INCL. LONG TERM TEMPERATURE CYCLING TESTS) WITHOUT ANY FINDING EXCEPT SOME MECHANICAL DAMAGES. THE PACEMAKER IS 17 YEARS OLD AND HAS NOT BEEN RETURNED FOR SERVICE TO OSYPKA MEDICAL BEFORE BUT HAS BEEN SERVICED BY A THIRD PARTY. THE INSPECTION STICKER ON THE HOUSING INDICATES THE NEXT CHECK-UP WILL BE DUE IN (B)(6)2025. ACCORDING TO OUR RECORDS THIS PACEMAKER WITH SN (B)(6) WAS SUBJECT TO A FIELD SAFETY CORRECTIVE ACTION IN 2010 (FDA RECALL NUMBER Z-2443-2010). EVEN IF THE DESCRIBED BEHAVIOR DOES NOT FULLY MATCH THERE IS THE POSSIBILITY THAT IT COULD HAVE RELATES TO THIS EVENT. ACCORDING TO OUR RECORDS THIS PARTICULAR DEVICE WITH SN (B)(6) HAD NOT BEEN RETURNED FOR THE UPDATE YES EVEN IF ALL CUSTOMERS HAD BEEN CONTACTED SEVERAL TIMES IN 2010. ACCORDING TO THE FSCA: AFTER INSERTING AN INCOMPATIBLE BATTERY WITH HIGHER OPEN CIRCUIT VOLTAGE THE ERROR MESSAGE "VENTRICULAR/ATRIAL LEAD DISCONNECTED" MAY BE DISPLAYED. AT THE SAME TIME AN AUDIBLE ALARM SOUNDS AND THE STIMULATION OF THE CORRESPONDING CHANNEL IS STOPPED. THIS PROBLEM HAS BEEN IDENTIFIED FOR THE S/N RANGE BETWEEN (B)(6) AND HAS BEEN SOLVED BY A FIELD SAFETY CORRECTIVE ACTION DATED ON (B)(6)2010. OSYPKA MEDICAL HAS EVALUATED WITH THE CUSTOMER IF OTHER DEVICES MAY BE STILL IN USE WHICH ALSO HAS NOT RECEIVED THE FSCA UPDATE. ON (B)(6)2025 A LIST OF ALL USED PACE 203H HAS BEEN PROVIDED AND OSYPKA MEDICAL COULD CONFIRM THAT SN (B)(6) WAS THE ONLY DEVICE WHICH HAD NOT YET RECEIVED THE UPDATE FROM THE FSCA FROM 2010.

    Description of Event or Problem · 0

    OSYPKA MEDICAL RECEIVED THE DEVICE FOR SERVICE WITH THE FOLLOWING FAILURE DESCRIPTION: "PACER WENT OFF AFTER BATTERY CHANGE, PACER DEPENDING PATIENT WENT ASYSTOLIC AFTER BATTERY CHANGE." THIS IS THE ONLY INFORMATION WE HAVE RECEIVED UNTIL THE DAY OF THE INITIAL REPORT. AFTER 2 ATTEMPTS TO CONTACT PEOPLE WHO ARE LISTED AS CONTACT PERSONS ON THE ACCOMPANYING SHIPPING DOCUMENT WE RECEIVED INFORMATION BY PHONE ON (B)(6)2024 THAT THE ONLY PERSON WHO COULD POSSIBLY PROVIDE FURTHER DETAILS WOULD NOT BE AVAILABLE AGAIN UNTIL (B)(6) 2025. FOLLOW UP INFORMATION RECEIVED ON 2025-01-10: - INCIDENT DATE IS STILL UNKNOWN; IT WAS APPROX. EARLY (B)(6) 2024. - AFTER BATTERY CHANGE THE PATIENT WENT ASYSTOLIC FOR APPROX. 30 SEC. - THE REPORTER COULD NOT CONFIRM IF THE PACER ACTUALLY SWITCHED OFF COMPLETELY OR STOPPED PACING FUNCTION AFTER BATTERY CHANGE AND WHETHER AN ERROR MESSAGE WAS DISPLAYED. - THE INITIAL REPORTER ALSO DID NOT RULE OUT HUMAN ERROR CAUSING THE INCIDENT. - IT WAS STATED THAT THE PATIENT SUFFERED NO PERMANENT INJURIES OR CONSEQUENCES DUE TO THE INCIDENT.

    Description of Event or Problem · 0

    OSYPKA MEDICAL RECEIVED THE DEVICE FOR SERVICE WITH THE FOLLOWING FAILURE DESCRIPTION: "PACER WENT OFF AFTER BATTERY CHANGE, PACER DEPENDING PATIENT WENT ASYSTOLIC AFTER BATTERY CHANGE." THIS IS THE ONLY INFORMATION WE HAVE RECEIVED UNTIL THE DAY OF THIS INITIAL REPORT. AFTER 2 ATTEMPTS TO CONTACT PEOPLE WHO ARE LISTED AS CONTACT PERSONS ON THE ACCOMPANYING SHIPPING DOCUMENT, WE RECEIVED INFORMATION BY PHONE ON (B)(6) 2024 THAT THE ONLY PERSON WHO COULD POSSIBLY PROVIDE FURTHER DETAILS WOULD NOT BE AVAILABLE AGAIN UNTIL (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121451 OSYPKA PACE 203H PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| O