BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2031397 · Received March 23, 2011

    Report

    Report Number
    1000165971-2011-00126
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    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 MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE ATTEMPTED IMPLANTATION OF THE ICD INVOLVED IN THIS MDR REPORT, A CONNECTION ISSUE OCCURRED WITH THE DF-1 CONNECTOR WHEN TRYING TO CONNECT THE LEAD. THE ICD WAS NOT IMPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2503

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention