BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2210693 · Received August 8, 2011

    Report

    Report Number
    1000165971-2011-00283
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 22, 2011
    Manufacturer
    SORIN C.R.M S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011, THE PHYSICIAN IMPLANTED THE ICD INVOLVED IN THIS MDR REPORT (ICD REPLACEMENT). THE IMPEDANCES WERE MEASURED AFTER LEADS CONNECTION, HOWEVER, ALL IMPEDANCES WERE ABOVE 3000 OHMS. THE PHYSICIAN DECIDED TO DISCONNECT AND CONNECT AGAIN THE LEADS, WITHOUT EFFECT ON MEASURED IMPEDANCES. THE PROGRAMMER WAS ALSO RESTARTED. THE ALL IMPEDANCES WERE NORMAL. THE PHYSICIAN REQUESTED AN EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN C.R.M S.R.L. PARADYM CRT 8750 2501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention