BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 2883819 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02883
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ICD WAS NOT INTERROGATABLE, CONFIRMING THE CLINICAL OBSERVATION. THE ICD WAS OPENED AND THE INNER ASSEMBLY WAS INSPECTED. DURING THE INSPECTION OF THE ELECTRICAL MODULE, THE ANALYSIS REVEALED THAT THE OUTPUT STAGES OF THE HIGH VOLTAGE CIRCUIT HAD BEEN DAMAGED. THIS DAMAGE INDICATES A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT. DUE TO THE DAMAGE OF THE ELECTRICAL MODULE, THE DEVICE COULD NOT BE INTERROGATED PROPERLY. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE OBSERVED DAMAGE SYMPTOMS. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE FLAWLESS. IN SUMMARY, THE ICD WAS DAMAGED DUE TO A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT. THE MANUFACTURING RECORDS DOCUMENT A FLAWLESS DEVICE PRODUCTION. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS ATTEMPTED BUT NOT IMPLANTED BECAUSE THE DEVICE STOPPED COMMUNICATING AND FUNCTIONING DURING THE IMPLANT PROCEDURE. THERE ARE NO ADVERSE PT EFFECTS REPORTED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 HF-T CRT - D MRM BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization