BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1477596 · Received July 8, 2009

    Report

    Report Number
    3004209178-2009-04678
    Event Type
    Malfunction
    Date Received
    July 8, 2009
    Report Date
    June 11, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED A BURNING SENSATION WHEN THE STIMULATION WAS TURNED ON. STIMULATION CHANGES WERE NOTED WITH MOVEMENT. THE FOLLOWING ELECTRODE IMPEDANCES WERE COLLECTED AT 6V/450PW (IMPEDANCES WERE IN THE HIGH RANGE OF NORMAL). C0:3697 <15; C1: 3697 <15; C2: 3697 <15; C3: 1470 28; 01: 1843 22; 02: 2920 <15; 03: 3697 <15; 12: 1843 22; 13: 2657 15. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL 3487A, LOT# J0104179V| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF015661N| EXPLANTED:| IMPLANTED: