BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 1983880 · Received February 4, 2011

    Report

    Report Number
    1000165971-2011-00062
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 24, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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, THE DEVICE AND THE LEADS (ISOLINE (B)(4)) WERE IMPLANTED ON (B)(6) 2010. THE PHYSICIAN OBSERVED THAT NOISE EPISODES LED TO INAPPROPRIATE SHOCK THERAPIES. THE LEAD WAS REPLACED ON (B)(6) 2010 AND THE ICD WAS KEPT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM DR 8550 2449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention