BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 4919592 · Received July 10, 2015

    Report

    Report Number
    9681449-2015-00002
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(4): DISTRIBUTION PARTNER (B)(4) INFORMED US ON (B)(6) 2015 ABOUT THE FOLLOWING PRODUCT PROBLEM: IT WAS REPORTED THE LEAD READILY "POPS OUT" AFTER IT IS TIGHTENED IN THE EXTERNAL PACING GENERATOR. THERE WAS NO PATIENT INVOLVEMENT AND THE PRODUCT REMAINS IN THE CATHERIZATION LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448945 MEDTRONIC EXTERNAL PACEMAKER DTE OSYPKA MEDICAL GMBH 5391

    Patients

    Seq Age Sex Outcome Treatment
    1