BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA GENERATOR

    MDR report key: 20079189 · Received August 23, 2024

    Report

    Report Number
    MW5158856
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Report Date
    August 6, 2024
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NON-(B)(6) GENERATOR PERSISTENTLY REPORTED EXCESSIVE IMPEDANCE. DESPITE CHANGING THE INDIFFERENT ELECTRODE, INCLUDING CABLES AND ADAPTER, AND EMPLOYING A NEW CATHETER WITH ITS CABLE, THE ISSUE PERSISTED. AFTER AN HOUR AND A HALF OF TROUBLESHOOTING, THE PROCEDURE WAS HATTED UNSUCCESSFULLY DUE TO THE INABILITY TO PERFORM ABLATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479865 OSYPKA GENERATOR PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown