BEUDAMED
    FDA Adverse Event Summary report: N

    LUMAX 300 VR-T

    MDR report key: 3173911 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-00575
    Date Received
    June 17, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD WAS FIRST SUBJECTED TO AN INTERROGATION WHERE THE DEVICE STATUS EOS WAS CONFIRMED. THE ICD WAS IMPLANTED FOR A PERIOD OF 3 MONTHS AND A CHARGING CYCLE WAS DOCUMENTED. FIRST AN ELECTRICAL ANALYSIS OF THE ICD'S MEMORY CONTENT WAS INVESTIGATED. THE REVIEW OF IEGMS SHOWED INAPPROPRIATE VF DETECTION DUE TO NOISE ON (B)(6) 2012, WHICH LED TO A CHARGE. DURING THE CHARGING PROCESS EOS WAS DETECTED. THE MORPHOLOGY OF THE SENSED INTERFERENCE IN THE VENTRICULAR CHANNEL, AS WELL AS THE EOS DETECTION WHICH OCCURRED DURING CHARGING IS MOST LIKELY DUE TO THE INFLUENCE OF A STRONG EXTERNAL MAGNETIC FIELD. NEXT, THE ICD SENSING WAS CHECKED AND FOUND TO BE FREE OF NOISE. THE ICD SENSED SIGNALS APPLIED TO FREE FROM INTERFERENCE. EVIDENCE OF A DEVICE MALFUNCTION WERE NOT AVAILABLE, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE EOS CONDITION WAS REMOVED WITH A TECHNICAL PROGRAMMING DEVICE, AND THE DEVICE WAS THEN RETURNED TO BOL. THE BATTERY VOLTAGE OF 3.06 V INDICATES A CHARGED BATTERY. 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 WAS FOUND TO BE WITHIN THE ELECTRICAL SPECIFICATIONS. IT IS MOST LIKELY THAT THE OBSERVED BEHAVIOR OF DEVICE RESULTED FROM INFLUENCE OF A STRONG EXTERNAL MAGNETIC FIELD SUCH AS AN MRI. THERE WERE NO SIGNS OF MATERIAL OR WORKMANSHIP DEFECTS.

    Description of Event or Problem · 1

    OUR MDR - AFTER AN IMPLANTATION TIME OF ABOUT 3 MONTHS, IT WAS REPORTED THAT THE ICD SHOWED EOS. NO DETERIORATION OF THE PT'S STATE OF DEATH WAS REPORTED. THE ICD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273690 LUMAX 300 VR-T ICD, PRODUCT CODE LWS LWS BIOTRONIK SE & CO. KG 335270

    Patients

    Seq Age Sex Outcome Treatment
    1