BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2090877 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03093
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED INTERMITTENT STIMULATION FROM THEIR DEVICE. IT WAS STATED THE DEVICE SHOWED IMPEDANCE READINGS OF <250 OHMS ON ELECTRODES 0-1, BUT THERAPY IMPEDANCES WERE ALL WITHIN NORMAL RANGE. IT WAS ALSO STATED THE PT WAS IN A CAR ACCIDENT TWO YEARS PRIOR. TROUBLESHOOTING WAS SUGGESTED, BUT NO PT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 52 YR LEAD: MODEL 3487A, LOT# J0511591V| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU069827V| IMPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL005810P| IMPLANTED:| EXPLANTED: