BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA VR

    MDR report key: 3790215 · Received May 5, 2014

    Report

    Report Number
    9614453-2014-01028
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. MODEL NUMBER D234VRG IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO THE HOSPITAL WITH CHEST DISTRESS AND WAS ADMITTED. IT WAS NOTED THAT THE PATIENT DEVELOPED A STORM OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. THE ICD DELIVERED TREATMENT, HOWEVER, (B)(4) FAILED SHOCKS WERE REPORTED AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266231 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D234VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death