BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR S

    MDR report key: 6036469 · Received October 18, 2016

    Report

    Report Number
    1028232-2016-03744
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Report Date
    September 19, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE "USAGE OF DEVICE" SHOULD BE REUSE. THE RETURNED EXTERNAL PACEMAKER WAS THOROUGHLY ANALYZED. IT WAS PRINCIPALLY CAPABLE TO PACE AND SENSE. HOWEVER, IT WAS FOUND DURING THE ANALYSIS THAT THE EXTERNAL DAMAGES TO THE OPERATING ELEMENTS DID NOT ALLOW FOR A PROPER OPERATION. DAMAGE AND SOILING WAS FOUND. THE HOUSING IS CRACKED SEVERAL TIMES AND FRACTURED, AND ALL SETTING WHEELS ARE HARD TO TURN BECAUSE OF THE DIRT. THE VISUAL AND MECHANICAL ANALYSIS, AS WELL AS THE FUNCTION CHECK, DID NOT SHOW ANY INDICATIONS OF A MATERIAL DEFECT OR MANUFACTURING ERROR. THE DEVICE WAS DAMAGED BY EXTERNAL IMPACTS.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE PULSE RATE OUTPUT OF THE DEVICE WAS TOO HIGH IN COMPARISON TO THE PROGRAMMED RATE. THE DEVICE WAS RETURNED TO BIOTRONIK. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE EVENT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688619 REOCOR S EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365528

    Patients

    Seq Age Sex Outcome Treatment
    1 Other