BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR ICD, US

    MDR report key: 5325418 · Received December 23, 2015

    Report

    Report Number
    2938836-2015-32663
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 14, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENTRICULAR OVERSENSING CAUSED BY P-WAVE SENSING WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848270 FORTIFY ASSURA VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1357-40Q 4634953

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention