BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDP 20/B

    MDR report key: 4212022 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003759
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE EXTERNAL PACEMAKER WAS INSPECTED. THE VISUAL AND MECHANICAL INSPECTION REVEALED NO ANOMALIES AND NO MANUFACTURING DEVIATION WAS FOUND. THE FUNCTIONAL ANALYSIS SHOWED AN ELEVATED CURRENT CONSUMPTION DEPLETING THE BATTERY. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. SUBSEQUENT INVESTIGATIONS REVEALED THAT AN ELECTRIC COMPONENT OF THE ELECTRONIC MODULE WAS DEFECT CAUSING AN ELEVATED CURRENT CONSUMPTION DEPLETING THE BATTERY. THE DEFECT WAS REPAIRED AND THE DEVICE PROVED TO BE FULLY FUNCTIONAL AFTERWARD. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. DESPITE THE CLINICAL OBSERVATION, THE INSPECTION OF THE MANUFACTURING PROCESS DID NOT REVEAL ANY CONSPICUITY. IT CAN BE ASSUMED THAT THIS IS A SINGULAR EVENT OF RANDOM NATURE. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM A DAMAGE OF AN ELECTRIC COMPONENT LEADING TO AN ELEVATED CURRENT CONSUMPTION DEPLETING THE BATTERY. THE MANUFACTURING RECORDS DOCUMENT A FLAWLESS DEVICE PRODUCTION. IT IS THEREFORE ASSUMED, THAT THE DAMAGE OCCURRED AFTER THE DEVICE SHIPMENT, HOWEVER, THE DATE OF OCCURRENCE WAS NOT DETERMINABLE.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE DEVICE TURNED OFF WHILE BEING CONNECTED TO THE PATIENT. THE TEST SHOWED LOW BATTERY STATUS. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THERE WERE NO DATES PROVIDED BY THE COUNTRY OF ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693176 EDP 20/B EXTERNAL PACEMAKER DTB BIOTRONIK SE & CO. KG 346765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization