BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2093307 · Received April 15, 2011

    Report

    Report Number
    1000165971-2011-00167
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    SORIN CRM 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) 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 DEVICE INVOLVED IN THIS MDR REPORT WAS IMPLANTED ON (B)(6) 2011. AT THIS TIME, AN INDUCTION TEST WAS PERFORMED. REPORTEDLY, ON (B)(6) 2011, THE PHYSICIAN PERFORMED A SECOND INDUCTION TEST; HOWEVER WHEN HE INTERROGATED THE DEVICE HE COULDN'T FIND THE CORRESPONDING EPISODE. THE PHYSICIAN ASKED FOR AN EXPLANATION. REVIEW OF PROVIDED PT FILES REVEALED THAT THE EPISODE CORRESPONDING TO THE INDUCTION TEST WAS AVAILABLE ON THE PT FILE DATED (B)(6) 2011 AT 10:29. THE MEMORY WAS RESET BY THE USER, WHICH EXPLAINS WHY THE EPISODE WAS NO LONGER AVAILABLE AT 10:35.

    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