BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER

    MDR report key: 10051916 · Received May 13, 2020

    Report

    Report Number
    9681449-2020-00004
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    January 16, 2020
    Report Date
    May 13, 2020
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER. DEVICE WAS TESTED AFTER THE EVENT ON (B)(6) 2020 BY MEDTRONIC TECHNICAL SERVICE CENTER. FINDINGS: DEVICE PASSED TEST WITHOUT FINDINGS, PATIENT CABLE WAS FOUND DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT DELIVER PACING. EVENT OCCURRED BEFORE USE AND THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514164 MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH 5391

    Patients

    Seq Age Sex Outcome Treatment
    1