BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT

    MDR report key: 2230577 · Received August 12, 2011

    Report

    Report Number
    1000165971-2011-00307
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SORIN BIOMEDICA
    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

    ICD LEAD BREAKAGE WAS REPORTED, WHICH INDUCED NOISE SENSING AND SEVERAL CHARGES WITHOUT DELIVERED SHOCKS. THE SUBJECT LEAD REMAINS IMPLANTED. ANOTHER LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT MRM SORIN BIOMEDICA SWIFT 1CT 4041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention