BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1864345 · Received October 7, 2010

    Report

    Report Number
    3004209178-2010-07692
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    January 1, 2007
    Report Date
    September 9, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION SYSTEM WAS EXPLANTED DUE TO THE PATIENT BEING "ELECTROCUTED" BY THE DEVICE. THE PATIENT FELL DOWN THE STAIRS TWICE FOLLOWING AN UNEXPECTED "SHOCKING" SENSATION. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANTED:| LEAD: MODEL 3587A, LOT# LB4556| EXPLANTED:| PROGRAMMMER: MODEL 7434A, LOT# NGL010853P| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU016477V| IMPLANTED:| IMPLANTED:| EXPLANTED: