BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER

    MDR report key: 14187942 · Received April 22, 2022

    Report

    Report Number
    9681449-2022-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 22, 2022
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER BUT WAS INVESTIGATED BY THE DISTRIBUTOR SERVICE CENTER. THE SERVICE PROTOCOL WAS PROVIDED TO THE MANUFACTURER ON (B)(6) 2022. ACCORDING TO THE SERVICE REPORT DATED (B)(6) 2022: DEVICE WAS RECEIVED IN A GOOD COSMETIC CONDITION. VISUAL CHECK OK . DEVICE WAS NOT DAMAGED. PACEMAKER WORKED WITHIN SPECIFICATION AND PASSED FUNCTIONAL TEST. IT COULD BE CONFIRMED THAT THE PACEMAKER DID NOT HAVE ANY DEFECT WHICH COULD HAVE CAUSED THE REPORTED PACING PROBLEM. POSSIBLE ROOT CAUSES OTHERS THAN THE PACEMAKER WOULD BE: CONTACT PROBLEMS BETWEEN LEAD AND TISSUE. CONTACT PROBLEMS BETWEEN LEAD AND PATIENT CABLE OR ADAPTER CABLE. DEFECT ADAPTER CABLE. INAPPROPRIATE PACEMAKER PARAMETER SETTING (EG. STIMULATION AMPLITUDE SET LOWER THEN CAPTURE THRESHOLD AND STIMULATION WAS INEFFECTIVE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO SIMULATE. THE EPG IS EXPECTED TO BE RETURNED FOR SERVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199685 MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH 5391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown