BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 HF-T

    MDR report key: 3002105 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00625
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    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 MOL1. THE DEVICE WAS IMPLANTED FOR 20 MONTHS AND 12 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

    THIS DEVICE WAS REMOVED DUE TO PATIENT PAIN. THE PATIENT EXPERIENCED PAIN WHEN MOVING ARM; THE PHYSICIAN NOTED THAT THE DEVICE HAD MIGRATED LATERALLY. THIS DEVICE WAS EXPLANTED ON (B)(6) 2013 AND REPLACED. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105491 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization