BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCOR

    MDR report key: 3650520 · Received January 15, 2014

    Report

    Report Number
    9681449-2014-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 15, 2014
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: WE SUSPECTED THAT THE COMBINED IMPEDANCE OF HEARTWIRES AND HEART TISSUE LOCATED BETWEEN THE ELECTRODES OF THE PACING WIRES ESTABLISHED A LOW IMPEDANCE ELECTRICAL CIRCUIT LESS THAN THE MINIMUM IMPEDANCE (200 OHMS) SPECIFIED FOR THE PACE 203H. THE FOLLOWING GRAPH ILLUSTRATES THE MAXIMUM OUTPUT (IN V SHOWN ON THE Y AXIS) VS. THE IMPEDANCE AS SEEN BY THE PACEMAKER. IF THE USER INCREASES THE AMPLITUDE OUTPUT IS INCREASED BEYOND THIS LEVEL, THE PACE 203H'S CURRENT LIMITER DETERMINES EXCESS CURRENTS, TERMINATES STIMULATION AND DISPLAYS THE WARNING MESSAGE "SHORT CIRCUIT."

    Description of Event or Problem · 1

    IN 5 PATIENTS USING THE COMBINATION OF PACE 203H EXTERNAL PACEMAKER AND A&E MEDICAL PACING WIRES LEAD TO WHAT THE PACE 203 INTERPRETED AS AN ELECTRICAL SHORT-CIRCUIT, STOPPING STIMULATION. THIS PROBLEM OCCURRED ONLY WHEN THE VENTRICULAR OUTPUT AMPLITUDE EXCEEDED ABOUT 15 V. THIS PROBLEM WAS REPRODUCABLE. TWO OF THE 5 PATIENTS WERE PACEMAKER-DEPENDENT AND REQUIRED INTERVENTION. IN ONE CASE IT TOOK REPORTEDLY ABOUT 25 SECONDS TO DIAL-BACK THE AMPLITUDE AND RESTORE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39103 OSCOR EXTERNAL PACEMAKER DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R