BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL MODEL 3077

    MDR report key: 3209895 · Received June 26, 2013

    Report

    Report Number
    9681449-2013-00001
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 30, 2013
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT OF INCIDENT: PM (PACEMAKER) SHOULD HAVE BEGUN STIMULATING AT AN INTRINSIC RATE LESS THAN 50 BPM, WHICH IT DID NOT OCCUR. IN CASE OF A HYPOTOXIC TRIGGERED HEART STANDSTILL IT IS DIFFICULT TO TELL IF MANUAL HEART CONTRACTIONS (CARDIAC MASSAGE) WOULD HAVE HELPED. PATIENT WAS REANIMATED AND HAS PSYCHOLOGICAL IMPACT AFTER THE EPISODE." THE CUSTOMER DID NOT RETURN THE DEVICE TO OUR DISTRIBUTOR OR MFR. BECAUSE THE PATIENT WAS MOVED BETWEEN TWO HOSPITALS, NO INFORMATION IS AVAILABLE OF THE S/N OF THE DEVICE IN QUESTION. HOSPITAL PERSONNEL BELIEVED THAT THE DEVICE WAS FUNCTIONAL BUT NOT PROPERLY CONNECTED TO THE PATIENT. OSYPKA MEDICAL BECAME AWARE OF THIS EVENT ON (B)(6) 2013. THIS REPORT FORM FDA 3500A IS A CONTINUATION OF FORM FDA WHICH WAS SUBMITTED TO THE FDA VIA INTERNET ON (B)(4) 2013 BY OSYPKA MEDICAL (B)(4) (THE MFR). (B)(4).

    Description of Event or Problem · 1

    DESCRIPTION OF INCIDENT: A ST. JUDE MEDICAL MODEL 3077 EXTERNAL PACEMAKER MANUFACTURED BY OSYPKA MEDICAL (B)(4) WAS USED AT (B)(6) HOSPITAL. OSYPKA MEDICAL RECEIVED AN E-MAIL BY ST. JUDE MEDICAL ON (B)(4) 2013 WITH AN ATTACHMENT (IN (B)(6) LANGUAGE) DATED (B)(4) 2013 REPORTING THE FOLLOWING INCIDENT (TRANSLATION FROM (B)(6) INTO ENGLISH ACCORDING TO OUR BEST EFFORTS): "ON (B)(6) 2013, THE TEMPORARY PACEMAKER WAS USED BECAUSE OF EPISODES WITH HEAVY BRADYCARDIA DUE TO AUTONOMY DYSFUNCTION. THE PATIENT EXPERIENCED AN ASYSTOLE AT 04:35 FOR 25 SECONDS, PROBABLY TRIGGERED FROM HYPOTOXY. THE PACEMAKER FAILED TO OVERTAKE THE RHYTHM AT BRADYCARDIA BELOW 50 BPM. INSPECTION OF THE PACEMAKER REVEALED THAT THE BLACK OUTPUT WIRE WAS DISCONNECTED FROM THE PM (PACEMAKER) AND THE CONNECTOR WAS PLUGGED IN VERY LOOSE. APPARENTLY, THE WIRE SHOULD HAVE BEEN SCREWED TIGHTER IN ORDER TO AVOID A DISCONNECTION DUE TO MOVEMENT OR TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291348 ST. JUDE MEDICAL MODEL 3077 EXTERNAL CARDIAC PACEMAKER (SSI) DTE OSYPKA MEDICAL GMBH 3077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R