BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVENTRA 7 VR-T DX DF-1 PROMRI

    MDR report key: 11091969 · Received December 29, 2020

    Report

    Report Number
    1028232-2020-05711
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 29, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    UDI-DI
    04035479136314
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA ANALYSIS SHOWED THAT THIS DEVICE IS AT EOS. THIS DEVICE WAS EXPLANTED. UPON RECEIPT, THE ICD WAS INTERROGATED, REVEALING THE EOS BATTERY STATUS, DETECTED ON (B)(6), 2020. THE ICD WAS IMPLANTED FOR ABOUT 33 MONTHS AND 11 CHARGING CYCLES WERE RECORDED IN THE DEVICES MEMORY. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THEREFORE, THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION REVEALED THE BOS BATTERY STATUS. THE ANALYSIS OF THE AVAILABLE IEGMS SHOWED NOISE IN ALL CHANNELS. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF EPISODE 397 CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING. IN ADDITION, THE DEVICE DATA REVEALED THAT MRI MODE WAS DETECTED BY THE DEVICE ON (B)(6), 2020. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. HOWEVER, BASED ON THE ANALYSIS RESULTS, IT IS REASONABLE TO ASSUME THAT THE NOISE AS WELL AS THE ACTIVATION OF THE EOS BATTERY STATUS WAS CAUSED BY EXTERNAL INFLUENCES SUCH AS A MEDICAL TREATMENT OR DIAGNOSTIC, INCLUDING STRONG MAGNETIC FIELDS AS USED BY MRI SCAN. IN GENERAL, IF A CHARGING CYCLE OCCURS IN AN EXTERNAL MAGNETIC FIELD, DEPENDING ON STRENGTH AND ORIENTATION, A SATURATION OF THE TRANSFORMER MAY APPEAR, LEADING TO A TEMPORARY DROP OF THE SUPPLY VOLTAGE BELOW THE EOS LEVEL, RESULTING IN THE EOS BATTERY STATUS. THIS DOES NOT REPRESENT A DEVICE MALFUNCTION. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND 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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THE DATA ANALYSIS SHOWED THAT THIS DEVICE IS AT EOS. THIS DEVICE WAS EXPLANTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE ONLY BASED ON THE RETURNED DEVICE DATA AS WELL AS THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. 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. THE RETURNED DEVICE DATA FROM DECEMBER 29, 2020 WERE INSPECTED. THE DATA CONFIRMS THAT THE ICD HAS REACHED THE EOS STATE ON (B)(6) 2020, PROBABLY DUE TO A TEMPORARY BATTERY VOLTAGE DROP. THE LAST HOME MONITORING MESSAGE FROM THIS DEVICE WAS RECEIVED ON (B)(6) 2020. ON THIS DATE THE DEVICE WAS IN BOL STATE. BASED ON DATA ANALYSIS THE ROOT CAUSE FOR THE UNEXPECTED EOS ACTIVATION WAS NOT DETERMINABLE AND CAN ONLY BE CLARIFIED BY AN ANALYSIS OF THE DEVICE ITSELF. HOWEVER, IT CANNOT BE EXCLUDED THAT THIS OCCURRENCE RESULTED FROM A DEFECTIVE COMPONENT, WHICH MAY COMPROMISE THE ABILITY OF THE DEVICE TO DELIVER THERAPY. THEREFORE AND IN ORDER TO EXCLUDE ANY POTENTIAL HARM FOR THE PATIENT WE WOULD LIKE TO RECOMMEND TO REPLACE THE DEVICE AND TO RETURN IT FOR ANALYSIS TO BIOTRONIK. OF COURSE, INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT DETERMINE DECISIONS ABOUT PATIENT CARE AND THE FREQUENCY OF FOLLOW-UP SESSIONS. THE ABOVE RECOMMENDATION IS BASED ON A PURELY TECHNICAL ASSESSMENT. SHOULD FURTHER RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    DEVICE REPORTS ERI WITH HM VALUE AT BOL 3.10 VOLTS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550475 INVENTRA 7 VR-T DX DF-1 PROMRI ICD LWS BIOTRONIK SE & CO. KG 399436 04035479136314

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male