BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2043266 · Received February 25, 2011

    Report

    Report Number
    1000165971-2011-00095
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 17, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS REPORT WAS IMPLANTED ON (B)(6) 2011. REPORTEDLY, DURING THE INTERROGATION PERFORMED THAT DAY, THE PHYSICIAN OBSERVED INADEQUATE SURFACE ECG (BAD QUALITY) ON THE PROGRAMMER SCREEN (REPORTEDLY NOT RELATED TO PT CABLE CONNECTION). AFTER THE INDUCTION PROCEDURE (A SHOCK WAS DELIVERED) THE PHYSICIAN OBSERVED THAT THE PROGRAMMER WAS OFF (POSSIBLY A PROGRAMMER CRASH). THE PROGRAMMER WAS THEN RE-BOOTED (TWICE), THUS RESTORING NORMAL SURFACE ECG QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM CRT 8750 2463

    Patients

    Seq Age Sex Outcome Treatment
    1