BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 740 HF-T

    MDR report key: 2953905 · Received February 5, 2013

    Report

    Report Number
    1028232-2013-00202
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS BOL. THE DEVICE WAS IMPLANTED FOR 4 MONTHS AND 4 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE INSPECTION OF THE ICD MEMORY REVEALED NO ANOMALIES. THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PAIN AT THE POCKET SITE. THE PATIENT IS A SMALL MAN AND THE PHYSICIAN CHOSE TO REPLACE THIS DEVICE WITH A SMALLER DEVICE PLACED "SUB-MUSCULAR" ON (B)(6) 2013. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT'S DEVICE HAD MIGRATED, WHICH HAD CAUSED THE REPORTED PAIN. AFTER THE CHANGE OUT, PATIENT WAS DISCHARGED HOME THE SAME DAY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47416 LUMAX 740 HF-T CRT-D MRM BIOTRONIK SE & CO. KG 365608

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization