BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER

    MDR report key: 5843613 · Received August 3, 2016

    Report

    Report Number
    1035166-2016-00141
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    February 18, 2016
    Report Date
    July 5, 2016
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AFTER INTERROGATION OF A SORIN PACEMAKER THE PATIENT WENT INTO COMPLETE AV BLOCK AND STARTED TO CONVULSE BECAUSE THE DEVICE STOPPED PACING. THEY IMMEDIATELY STARTED WITH EXTERNAL CARDIAC MASSAGE AND BROUGHT THE PATIENT TO THE CATH LAB. THERE THEY IMPLANTED AN EXTERNAL PACING LEAD BUT THEY WHERE NOT ABLE TO PACE WITH THE EXTERNAL 5391 PM. THEY CHANGED TO ANOTHER EXT. PM (5388) AND IT WORKED. THE DEVICE WILL BE SEND BACK FOR A FUNCTIONALITY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494479 MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER 5391 DTE OSYPKA MEDICAL GMBH 5391 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SORIN PACEMAKER