BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 2883512 · Received December 21, 2012

    Report

    Report Number
    9614453-2012-00386
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    July 15, 2008
    Report Date
    November 30, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE US. (B)(4). THE DEVICE WAS NOT RETURNED AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND HOSPITALIZED DUE TO AN "ELECTRICAL STORM". THE PATIENT REMAINED HOSPITALIZED AND DIED SEVEN DAYS LATER. THE CAUSE OF DEATH WAS REPORTED AS SUDDEN CARDIAC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NIK IPG MFG SWITZERLAND C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death