BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVENTRA 7 HF-T QP DF4 IS4

    MDR report key: 6842256 · Received September 5, 2017

    Report

    Report Number
    1028232-2017-03126
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 29, 2017
    Report Date
    August 30, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2017 - THIS DEVICE WAS EXPLANTED ON (B)(6) 2017. ADDED EXPLANT DATE. UPON RECEIPT, THE DEVICE COULD BE PROPERLY INTERROGATED USING A CLINICAL PROGRAMMER. THE BATTERY STATUS WAS EOS AND SEVEN CHARGING CYCLES WERE RECORDED IN THE DEVICES MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE AVAILABLE IEGMS SHOWED EXTERNAL INTERFERING SIGNALS IN ALL CHANNELS ON 24-APR-2017. THIS LED TO THE DETECTION OF A VF EPISODE WHICH RESULTED IN THE CHARGING OF A DEFIBRILLATION SHOCK. THE CHARGING WAS ABORTED DUE TO THE DETECTION OF THE BATTERY STATUS EOS. THE FREQUENCY AND MORPHOLOGY OF THE SENSED INTERFERING SIGNALS CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING (MRI). IN GENERAL, IF A CHARGING CYCLE OCCURS IN A STRONG EXTERNAL MAGNETIC FIELD, DEPENDING ON STRENGTH AND ORIENTATION, A SATURATION OF THE HIGH VOLTAGE TRANSFORMER MAY APPEAR, LEADING TO A TEMPORARY DROP OF THE SUPPLY VOLTAGE BELOW THE EOS LEVEL, RESULTING IN THE OBSERVED EOS BATTERY STATUS. THIS OBSERVATION DOES NOT REPRESENT A BATTERY OR HYBRID MALFUNCTION. THEREFORE, THE EOS STATUS WAS REMOVED USING A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE BATTERY STATUS BOS. THE BATTERY VOLTAGE OF 3.09V REVEALED A CHARGED BATTERY. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE APPLIED HEART SIGNALS FREE OF NOISE PROVING THE SENSING FUNCTION TO BE AS EXPECTED. AFTERWARDS, THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A NORMAL AND EXPECTED SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN CONCLUSION, AN INCOMING INTERROGATION OF THE DEVICE CONFIRMED THE EOS BATTERY STATUS. AFTER REPROGRAMMING THE DEVICE WITH A TECHNICAL PROGRAMMER THE ICD SHOWED THE BATTERY STATUS BOS WITH A CHARGED BATTERY. THE ANALYSIS REVEALED THAT THE ICD WAS FULLY FUNCTIONAL. BASED ON THE ANALYSIS RESULTS, THE ACTIVATION OF THE EOS STATUS CAN BE ATTRIBUTED TO THE PRESENCE OF A STRONG EXTERNAL ELECTROMAGNETIC FIELD, PRESUMABLY AN MRI SCAN. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6) 2017 THIS DEVICE WAS EXPLANTED ON (B)(6) 2017. ADDED EXPLANT DATE. WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    DEVICE SHOWED EOS AT INTERROGATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622884 INVENTRA 7 HF-T QP DF4 IS4 CRT-D NIK BIOTRONIK SE & CO. KG 393012

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR