BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 1800915 · Received August 10, 2010

    Report

    Report Number
    1000165971-2010-00865
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY, THE ICD INVOLVED IN THIS MDR REPORT REVEALED LONG CHARGE TIME DURING TESTS BEFORE THE IMPLANTATION (36 SECONDS AND 26 SECONDS). THE ICD WAS NOT IMPLANTED AND WAS RETURNED FOR ANALYSIS. ANOTHER PARADYM ICD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM CRT 8750 2448

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization