BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3022735 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00157
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PT WAS ADMITTED AT THE HOSPITAL BECAUSE HE UNDERWENT AN ARRHYTHMIA AND REC'D 150 SHOCKS FROM THE ICD INVOLVED IN THIS MDR REPORT. UPON INTERROGATION OF THE DEVICE WITH THE ASSOCIATED PROGRAMMER, A WARNING MESSAGE FOR "CHARGE TIME > 40'S" WAS DISPLAYED. THE ARRHYTHMIA EGM EPISODES WERE DISPLAYED AND PRINTED DURING THE INTERROGATION. THEN THE SESSION WAS CLOSED AFTER SAVING; HOWEVER, WHEN TRYING TO REVIEW RECORDED FILE, NO EPISODES WERE DISPLAYED. AS THE BATTERY VOLTAGE REACHED THE ELECTIVE REPLACEMENT INDICATOR (2.1 V), THE DEVICE WAS THEN EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119588 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention