BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1822583 · Received August 27, 2010

    Report

    Report Number
    3004209178-2010-06541
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    April 23, 2007
    Report Date
    July 30, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFECTION. SPECIFICALLY, THERE WAS A SKIN EXCORIATION OVER THE NEUROSTIMULATOR SITE, WITH THE DEVICE EXPOSED. THE NEUROSTIMULATOR WAS ALSO DEPLETED. THE DEVICE WAS REPLACED AND THE PT RECOVERED WITHOUT SEQUELAE.

    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 47 YR Required Intervention PROGRAMMER: MODEL 7434A, LOT# NGL020440P| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU039342V| LEAD: MODEL 3587A, LOT# LA8656| EXPLANTED:| IMPLANTED: