BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3992928 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01941
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS DUE TO SUPRA VENTRICULAR TACHYCARDIA (SVT). 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
    467259 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D234DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening