BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1547829 · Received November 18, 2009

    Report

    Report Number
    6000032-2009-08523
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Date of Event
    October 23, 2009
    Report Date
    October 23, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    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

    NO SPECIFIC SIGNS OR SYMPTOMS WERE EXPERIENCED BY PT. IMPEDANCE READINGS WERE >4000 OHMS ON ALL OF THE BIPOLAR PAIRS AND QUESTION MARKS WERE ALSO SEEN (CO: ???, C1: >4,000 OHMS, C2: 3243 OHMS, C3: 860 OHMS, 01:3243 OHMS, 02: 4,000 OHMS, 03: ???, 12: 2426 OHMS, 13: 3896 OHMS, 23: 2426, OHMS). AFTER RAISING DEFAULT SETTINGS TO RECOMMENDED 3.0 VOLTS AND PW OF 450 THE BEST ELECTRODES TO REPROGRAM PT WERE ABLE TO BE DETERMINED. THE PT LEFT WITH STIMULATION IN ALL OF HIS AREAS OF PAIN AND STATED HE FELT BETTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL: 7495-51, LOT# XR0043365N| PROGRAMMER: MODEL 7434, LOT# YN0013773P| EXPLANTED:| LEAD: MODEL 3587A, LOT# L45134| IMPLANTED: