BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1960312 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01012
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DECEMBER 15, 2010. 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 MDR WAS IMPLANTED ON (B)(6) 2010. DURING ANALYSIS OF THE STORED FILES RELATED TO THIS PT (FILES FROM IMPLANT AND FROM FOLLOW-UPS DATED (B)(6), (B)(6) AND (B)(6) 2010), IT WAS NOTED THAT THE "ARRHYTHMIA AND THERAPY HISTORY" SCREEN WAS SHOWING INFORMATION RELATED TO 2 VENTRICULAR FIBRILLATION (VF) EPISODES RECORDED ON (B)(6) 2010, I.E. PRIOR TO THE DATE OF IMPLANT. THE CUSTOMER RAISED SOME QUESTIONS. IT WAS NOTED THAT ALL PT FILES SHOW SLIGHTLY DIFFERENT TIME OF OCCURRENCE FOR THESE VF EPISODES DATED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM DR 8550 2405

    Patients

    Seq Age Sex Outcome Treatment
    1