BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 20267579 · Received September 20, 2024

    Report

    Report Number
    9681449-2024-00003
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 20, 2024
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MDR REPORT# MW5158856 DID NOT PROVIDE ENOUGH INFORMATION TO IDENTIFY THE MODEL WHICH WOULD HAVE BEEN INVOLVED IN THE REPORTED EVENT. SINCE THERE WAS NO INFORMATION ABOUT THE REPORTER OR DETAILS ABOUT THE HOSPITAL THERE WAS NO CHANCE TO DO ANY FURTHER INVESTIGATION. OBVIOUSLY THE REPORTER IS NOT AVAILABLE TO GIVE MORE DETAILS ABOUT THE DEVICE (MODEL, SN). THERE ARE CERTAIN DOUBTS THAT THIS INCIDENT IS ACTUALLY RELATED TO AN EXTERNAL PACEMAKER AT ALL. THE SENTENCE: "THE PROCEDURE WAS HATTED UNSUCCESSFULLY DUE TO THE INABILITY TO PERFORM ABLATION." LEADS TO CONJECTURE THAT THE REPORTER IS REFERRING ACTUALLY TO A RF GENERATOR FOR CATHETER ABLATION. OSYPKA MEDICAL GMBH IS NOT MANUFACTURING SUCH DEVICES.

    Description of Event or Problem · 0

    MANUFACTURER RECEIVED VOLUNTARY AND ANONYMOUS MDR REPORT# MW5158856: "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)" ACCORDING TO THE MDR REPORT AN EXTERNAL PACEMAKER WAS INVOLVED BUT NO MODEL NAME OR SERIAL NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354081 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other