BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 5410481 · Received February 4, 2016

    Report

    Report Number
    3004209178-2016-01528
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    February 3, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CHRONIC LOW BACK PAIN AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED INTERMITTENT STIMULATION. IMPEDANCE TESTING WAS PERFORMED AT 3 VOLTS AND RESULTS SHOWED NORMAL FUNCTION OF THE DEVICE C0: 600 OHMS 31 UA;C1: 496 OHMS 37UA;C2: 496 OHMS 37 UA;C3: 600 OHMS 31 UA;01: 755 OHMS 24 UA;02: 1004 OHMS 18 UA;03: 1015 OHMS 18 UA;12: 755 OHMS 24 UA;13: 807 OHMS 23 UA;23: 755 OHMS 24UA. THERAPY IMPEDANCE SHOWED 920 OHMS AND 55 UA. THEY ALSO REPORTED THE PATIENT PROGRAMMER WAS ALSO HAVING DIFFICULTY WITH CONNECTIONS. THE PATIENT TRIED MULTIPLE TIMES BEFORE SHE WAS ABLE TO CONNECT WITH THE DEVICE. A REPLACEMENT PATIENT PROGRAMMER WAS DECLINE BY THE PATIENT BECAUSE SHE WOULD BE SCHEDULING IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67940 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR