BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICOR 7 VR-T DX DF4 PROMRI

    MDR report key: 19691336 · Received July 8, 2024

    Report

    Report Number
    1028232-2024-03634
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 4, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    UDI-DI
    04035479156701
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND THOROUGHLY ANALYZED, CONFIRMING THE REPORTED VF AND THE INEFFICIENT TERMINATION THROUGH ICD SHOCK THERAPY. ANALYSIS OF THE DEVICES SHOCK AND EPISODE HOLTER INDICATES SUCCESSFUL VF DETECTION FOLLOWED BY DELIVERY OF SHOCKS PROGRAMMED AT 40J (EPISODE 231-232 ON MAY 28, 2024), BOTH ALIGNING WITH THE EXPECTED BEHAVIOR BASED ON THE PROGRAMMED PARAMETERS. THE DEVICE DELIVERED 8 SHOCKS TO TERMINATE THE VF EPISODE, HOWEVER, TERMINATION WAS NOT ACHIEVED. AS PER THE DEVICE SPECIFICATIONS AND PROGRAMMED PARAMETERS, UP TO 8 SHOCKS CAN BE DELIVERED WITHIN A SINGLE VF EPISODE, HENCE THE MAXIMUM NUMBER OF SHOCKS WERE DELIVERED BY THE DEVICE FOR THIS PARTICULAR VF EPISODE. THE DEVICE DATA REVEALED NO SIGNS OF A DEVICE MALFUNCTION. EXTERNAL SHOCK THERAPY SUCCESSFULLY TERMINATED THE VF EPISODE. THE ICD UNDERWENT A COMPREHENSIVE ELECTRICAL ANALYSIS. THE DEVICES ABILITY TO DELIVER THERAPIES WAS CONFIRMED. ANTI-BRADYCARDIA PACING PULSES WERE FOUND TO BE NORMAL, WITH BOTH AMPLITUDE AND FREQUENCY MATCHING THE PROGRAMMED SETTINGS. WHEN A FIBRILLATION SIGNAL WAS APPLIED, THE DEVICE SUCCESSFULLY DELIVERED DEFIBRILLATION SHOCKS AT VARIOUS SPECIFIED ENERGY LEVELS AND PHASES, DEMONSTRATING NORMAL AND EXPECTED SENSING AND SHOCK DELIVERY. NOTABLY, THE SPECIFIED ENERGY LEVELS WERE ACHIEVED AS PROGRAMMED. IN CONCLUSION, A COMPREHENSIVE ANALYSIS OF THE DEVICES MEMORY AND FUNCTIONALITY DEMONSTRATED THAT THE ICD IS FULLY OPERATIONAL, WITH NO EVIDENCE OF MALFUNCTION.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED AFTER PT. WAS ADMITTED TO ER BY EMS (B)(6) 2024 AFTER HAVING VF ARREST WITH FAILED ICD SHOCK, AND SYNCOPAL EVENT (PT. MAY HAVE TAKEN FENTANYL, BUT DOES NOT REMEMBER). THE RV LEAD WAS UNABLE TO BE REMOVED DURING PROCEDURE DUE TO ADHESIONS AT SITE OF THE COIL AND NO REPLACEMENT ICD WAS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134699 ACTICOR 7 VR-T DX DF4 PROMRI ICD LWS BIOTRONIK SE & CO. KG 429525 04035479156701

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization