BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1873377 · Received September 17, 2010

    Report

    Report Number
    1000165971-2010-00896
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 23, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., 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

    ON (B)(4) 2010: THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE US. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR REPORT WAS IMPLANTED ON (B)(6) 2010. DURING THE IMPLANT PROCEDURE, VENTRICULAR FIBRILLATION (VF) INDUCTION PROCEDURES WERE PERFORMED. REPORTEDLY, THE NUMBER OF PACING PULSES DELIVERED BEFORE THE SHOCK ON T-WAVE - DURING THE VF INDUCTION PROCEDURES - WAS INADEQUATE (DIFFERENT FROM THE PROGRAMMED VALUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM DR 8550 2453

    Patients

    Seq Age Sex Outcome Treatment
    1