BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3181834 · Received June 14, 2013

    Report

    Report Number
    1000165971-2013-00298
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO HOSPITAL BECAUSE OF THE SHOCK THERAPIES DELIVERED BY THE ICD. INDEED, ACCORDING TO THE ARRHYTHMIA AND THERAPY HISTORY, SIX SHOCKS WERE DELIVERED FOLLOWING A VENTRICULAR TACHYCARDIA (VT) DETECTED ON THAT DAY. HOWEVER, THE CORRESPONDING EPISODE WAS NOT RECORDED IN DEVICE MEMORY. SINCE THE VT WAS SUSTAINED, TWO MANUAL SHOCKS WERE DELIVERED TO REDUCE THIS ARRHYTHMIA. NORMAL MEASUREMENTS WERE PERFORMED AFTERWARDS. AN EXPLANATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271834 PARADYM MRM SORIN GROUP ITALIA S.R.L. PARADYM DR 8550 2533

    Patients

    Seq Age Sex Outcome Treatment
    1