BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4181360 · Received August 20, 2014

    Report

    Report Number
    3009448963-2014-00190
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 5, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHEST X-RAYS AND DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER REVIEW. A TS CONSULTANT DISCUSSED THAT THE ELECTRODE POSITION WAS NOT OPTIMAL AND THAT A REPOSITIONING OF THE ELECTRODE SHOULD BE CONSIDERED. ADDITIONAL TROUBLESHOOTING WAS PROVIDED REGARDING THE OPTIMAL SENSING VECTOR. AT THIS TIME, THE S-ICD AND ELECTRODE REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFO IS AVAILABLE. ONCE ANY ADDITIONAL INFO DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXPERIENCED A VENTRICULAR TACHYCARDIA (VT). THE SYSTEM DETECTED THE VT AND DELIVERED A SHOCK; HOWEVER, THE SHOCK DID NOT CONVERT THE VT, BUT RATHER ACCELERATED THE RHYTHM INTO A POLYMORPHIC VENTRICULAR FIBRILLATION (VF). TWO MORE SUBSEQUENT SHOCKS WERE DELIVERED, BUT DID NOT CONVERT THE ARRHYTHMIA. AFTER THE THIRD SHOCK, THE VF MORPHOLOGY CHANGED INTO A VERY FINE VF, RESULTING IN UNDERSENSING AND THE END OF THE EPISODE DESPITE THE VF CONTINUING. THE VF WAS THEN DETECTED AGAIN AND TWO SHOCKS WERE DELIVERED. THE SECOND SHOCK SUCCESSFULLY CONVERTED THE VF INTO NORMAL SINUS RHYTHM. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVAL. THE TS CONSULTANT CONFIRMED THE NON-CONVERSION, RHYTHM ACCELERATION, AND UNDERSENSING. A REVIEW OF THE SHOCK IMPEDANCE MEASUREMENTS FOUND ALL VALUES TO BE IN NORMAL ISSUE. IT WAS ALSO CONFIRMED BY THE FIELD THAT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS NOT PERFORMED AT IMPLANT. THE TS CONSULTANT DISCUSSED THAT CHEST X-RAY EVAL OF THE SYSTEM SHOULD BE CONSIDERED TO ENSURE THAT THE SYSTEM WAS IMPLANTED IN AN OPTIMAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500682 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 1010