BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA SR-T PROMRI

    MDR report key: 2891753 · Received November 21, 2012

    Report

    Report Number
    1028232-2012-02904
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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 PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE INSPECTION REVEALED THAT THE DEVICE WAS NEITHER INTERROGATABLE NOR WAS ANY OUTPUT SIGNAL PRESENT. THEREFORE, THE PACEMAKER WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. DESPITE OF A SLIGHTLY ELEVATED CURRENT CONSUMPTION, THE BATTERY WAS FOUND TO BE STILL SUFFICIENTLY CHARGED. SUBSEQUENT INVESTIGATIONS REVEALED A DAMAGED CAPACITOR LEADING TO THE CLINICAL OBSERVATION. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE FLAWLESS. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM A DAMAGED CAPACITOR. 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.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO INTERROGATE THE DEVICE DURING THE IMPLANTING PROCEDURE. THE PHYSICIAN DECIDED TO IMPLANT A NEW DEVICE. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIA SR-T PROMRI PACEMAKER NVZ BIOTRONIK SE & CO. KG 371998

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization