BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000094-2013-00082

    MDR report key: 3278325 · Received August 10, 2013

    Report

    Report Number
    6000094-2013-00082
    Event Type
    Injury
    Date Received
    August 10, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWP
    Adverse Event
    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S FAMILY MEMBER THAT THE PATIENT DEVELOPED HYDROPERICARDIUM SOON AFTER DEVICE IMPLANT. IT IS UNKNOWN WHETHER THERE WAS MEDICAL INTERVENTION. 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
    382733 LWP MEDTRONIC S.A. (SMO) MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Life Threatening