BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER

    MDR report key: 11054784 · Received December 22, 2020

    Report

    Report Number
    9681449-2020-00008
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 22, 2020
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER. HOWEVER, THE MANUFACTURER IS IN CONTACT WITH THE DISTRIBUTOR AND IMPORTER IN ORDER TO RECEIVE IT FOR TESTING. ON THE SAME DATE ANOTHER INCIDENT WAS REPORTED FROM THIS FACILITY WITH ANOTHER DEVICE. IT COULD BE ASSUMED THAT ROOT CAUSE OF THE TEMPORARY PACING PROBLEMS WAS A PROBLEM WITH THE LEAD SYSTEM (CONTACT PROBLEMS BETWEEN LEAD AND TISSUE OR LEAD AND PATIENT CABLE OR ADAPTER CABLE OR ANY DAMAGE OF CABLE OR ADAPTER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) EXPERIENCED INTERMITTENT PACING ISSUES. THE EPG IS EXPECTED TO BE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 2020-12-16: DEVICE WILL NOT BE RETURNED, BIO-MED INDICATES THE DEVICE IS PAST LIFE EXPECTANCY AND WILL NO LONGER BE SERVICED. SERVICE REPORT NOT AVAILABLE, AS DEVICE WILL NOT BE RETURNED. NO REFERENCE TO EXTENSION CABLE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522402 MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH 5391

    Patients

    Seq Age Sex Outcome Treatment
    1