BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 3149166 · Received May 30, 2013

    Report

    Report Number
    MW5030421
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 30, 2013
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF INCIDENT: ON (B)(6) 2013, A ST. JUDE MEDICAL MODEL 3077 EXTERNAL PACEMAKER MANUFACTURED BY OSYPKA MEDICAL (B)(4) WAS USED AT (B)(6) HOSPITAL, ON (B)(6) 2013 WITH AN ATTACHMENT IN (B)(6) LANGUAGE DATED (B)(6) 2013 REPORTING THE FOLLOWING INCIDENT TRANSLATION FROM (B)(6) TO (B)(6) ACCORDING TO OUR BEST EFFORTS: "ON (B)(6) 2013, THE TEMPORARY PACEMAKER WAS USED BECAUSE OF EPISODES WITH HEAVY BRADYCARDIA DUE TO AUTONOMY DISFUNCTION. THE PT EXPERIENCED ANY 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. RESULT OF INCIDENT: PM PACEMAKER SHOULD HAVE BEGUN STIMULATING AT A INTRINSIC RATE LESS THAN 50 BPM, WHICH DID NOT OCCUR. IN CASE OF A HYPOTOXIC TRIGGERED HEAT CONTRACTIONS CARDIAC MASSAGE WOULD HAVE HELPED. PT WAS REANIMATED AND HAS PSYCHOLOGICAL IMPACT AFTER THE EPISODE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237675 ST. JUDE MEDICAL EXTERNAL CARDIAC PACEMAKER DTB OSYPKA MEDICAL GMBH 3077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L