BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADYM

    MDR report key: 2850882 · Received November 16, 2012

    Report

    Report Number
    1000165971-2012-00438
    Event Type
    Death
    Date Received
    November 16, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: THE PROGRAMMER FILES WERE REVIEWED. CONCLUSION: THE ICD BEHAVED AS EXPECTED AND THERE WAS NO INDICATION FOR A LEAD DEFECT. CONSIDERING THE SPECIFIC PHYSIOLOGY OF THIS PT (LOW AMPLITUDE OF SOME VF COMPLEXES AND VF RATE AROUND 200MIN-1), DIFFERENT PROGRAMMED SETTINGS (E.G. LOWER VF ZONE THRESHOLD AND/OR LOWER PROGRAMMED VENTRICULAR SENSITIVITY VALUE) MIGHT HAVE HELPED REDUCE THE DELAY FOR VF DETECTION - AND FOR SUBSEQUENT SHOCK THERAPIES - IN THIS SPECIFIC CASE.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2012, COMPANY REPRESENTATIVE CAME TO HOSPITAL FOR AN EMERGENCY DEVICE CHECK, BUT PT'S DEATH WAS ALREADY CONFIRMED UPON HIS/HER ARRIVAL. ICD INTERROGATION SHOWED THAT A SHOCK THERAPY WAS DELIVERED, WHICH SUCCESSFULLY STOPPED VENTRICULAR FIBRILLATION. SEVERAL OTHER SHORT VP EPISODES HAD BEEN RECORDED BEFORE AND AFTER SHOCK DELIVERY, BUT NONE OF THEM REQUIRED THERAPY. ANALYSIS SHOWED THAT THE ICD BEHAVED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2501

    Patients

    Seq Age Sex Outcome Treatment
    1 Death