BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSYPKA PACE 203H

    MDR report key: 10521079 · Received September 11, 2020

    Report

    Report Number
    9681449-2020-00007
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    August 22, 2020
    Report Date
    September 11, 2020
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER WITH S/N (B)(4) HAS BEEN RETURNED BY THE CUSTOMER FOR EVALUATION - RECEIVED BY THE MANUFACTURER ON 27-AUG-2020. INITIAL TESTING DID NOT FIND ANY MALFUNCTION ONLY SOME MECHANICAL/ COSMETICALLY DAMAGES. FOLLOWING LONG TERM TESTING WAS COMPLETED WITHOUT ANY FINDINGS. THE DEVICE WORKED WITHIN ITS SPECIFICATION. THE CUSTOMER HAS BEEN CONTACTED VIA THE LOCAL DISTRIBUTION PARTNER. POSSIBLE ROOT CAUSED HAS BEEN DISCUSSED. ALL AGREED ON THE FOLLOWING: IT IS NOT CLEAR THAT R-ON-T PACING (INITIALLY SUSPECTED BY THE CLINIC PERSONAL) HAS BEEN HAPPENED. NO ECG RECORDS COULD HAVE BEEN PROVIDED FROM THE EVENT ITSELF PROOFING THIS. ARRHYTHMIA COULD HAVE BEEN ALSO INTRINSICALLY DEVELOPED AT POST HEART SURGERY PATIENT. IF R-ON-T PACING HAPPENED IT COULD HAVE CAUSED BY THE FOLLOWING REASONS OTHER THAN MALFUNCTION: UNDERSENSING - SENSING PROBLEMS DUE TO LEAD CONNECTION PROBLEMS CAUSED PACEMAKER TO ASYNCHRONOUS PACING. THE PERSONNEL REPORTED THAT HE PATIENT PULLED ON THE WIRES THE NIGHT BEFORE THE EVENT. PACEMAKER SWITCHED TO ASYNCHRONOUS PACING DUE TO THE PRESENCE OF INTERFERENCES. THIS IS A COMMON SAFETY FEATURE ON EXTERNAL PACEMAKERS. TO AVOID THAT NOISE SIGNALS FROM EXTERNAL SOURCES ARE MISINTERPRETED AS INTRINSIC ACTIVITY THE PACEMAKER SWITCHES INTO ASYNCHRONOUS PACING. IT HAS BEEN AGREED ON THAT AFTER THE REPAIR OF THE MECHANICAL DAMAGES THE DEVICE WILL BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE FOLLOWING HAS BEEN REPORTED BY THE HOSPITAL: CARDIAC ARREST ON CTW D2 POST-OP - POSSIBLE R ON T INAPPROPRIATE EPICARDIAL PACING CAUSING VF ARREST. ON (B)(6)- 81M EMERGENCY ADMISSION TO (B)(6) AFTER IN-HOSPITAL VF ARREST (SUSPECTED R ON T ? FROM PACING BOX). BG: D-2 RT.ATRIAL MYXOMA EXCISION AND TRANSFERRED TO WARD ON (B)(6). DT: ~15MINS. HPI: 07:00- PATIENT WAS ATTENDED BY THE SHO FOR FEELING LIGHTHEADED, WAS HEMODYNAMICALLY STABLE, 1-2S OF NSVT ON MONITOR. 07:15:- NSVT QUICKLY TRANSLATED TO PULSELESS VT, CPR COMMENCED -> VF ON MONITOR REQUIRING 3 CYCLE OF CPR 3XDCCV + 300MG AMIODARONE IV, 07:30- ROSC FOLLOWED BY 1X VF, 1DCCV-> ROSC WITH EPICARDIAL PACING. 08:00- TRANSFERRED TO (B)(6) FOR FURTHER MANAGEMENT. PREVIOUS ADMISSION: #ELECTIVE ADMISSION FOR EXCISION OF RIGHT ATRIAL MYXOMA (ON PUMP) - (B)(6) 2020. BG: INCIDENTAL FINDING OF RIGHT ATRIAL MASS, CT THORAX - DEMONSTRATED RIGHT ATRIAL MASS #UNEVENTFUL SURGERY. #DISCHARGE FROM (B)(6) D1 PM - UNEVENTFUL RECOVERY - SR WITH EPICARDIAL PACING SET AT VVI50. ECG - PRE-ARREST ?INAPPROPRIATE V PACING ALTHOUGH PACING SPIKES ARE SMALL. POSSIBLE CAUSE FOR ARREST IS INAPPROPRIATE PACING ALTHOUGH PACING BOX WAS SET WITH AT 5.O V OUTPUT WITH 2.0 V SENSING. IT WAS ALSO REPORTED THAT: THE NIGHT BEFORE EVENT OVERNIGHT ON (B)(6) THE PATIENT WAS DELIRIOUS / RESTLESS AND WAS NOTED TO HAVE BEEN [?]PULLING AT HIS WIRES'. DEVICE SETTINGS: PACING MODE: VVI, RATE: 40 PPM, OUTPUT VOLTAGE: 5V, SENSITIVITY 2.0 MV. ATTACHED ECG RECORDS PROVIDED BY HOSPITAL SHOW PRE-ARREST ECGS TAKEN ON (B)(6) 2020 HOSPITAL STAFF DOCUMENTED ALSO SENSING PROBLEMS AND A LEAD SWAP FROM VVI TO AAI THE PATIENT HAS RECOVERED WELL AND IS EXPECTED TO MAKE A COMPLETE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988465 OSYPKA PACE 203H EXTERNAL PULSE GENERATOR DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening