BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 2954590 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00465
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MANY INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RVR (RAPID VENTRICULAR RATE). IT WAS ALSO OBSERVED THAT AF HAD OCCURRED IN THE ELECTROCARDIOGRAM TAKEN AT THE CHECK AND V-RATE (VENTRICULAR-RATE) HAD ENTERED INTO TDI (TACHY DETECT INTERVALS) MANY TIMES. THE DEVICE'S RATE CONTROL WAS REPROGRAMMED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57932 SECURA VR LWS IPG MFG SWITZERLAND D234VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention