BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1940666 · Received December 17, 2010

    Report

    Report Number
    3004209178-2010-10578
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT JUST HAD SURGERY AND WAS NOT ABLE TO FEEL STIMULATION. THEY WERE NOT ABLE TO ADJUST STIMULATION: LOWER AND UPPER LIMITS WERE REACHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 75 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU008461V| LEAD: MODEL 3986ILC, LOT# N26493| PROGRAMMER: MODEL 7434A, LOT# NGL011355P