BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 4828131 · Received June 9, 2015

    Report

    Report Number
    6000032-2015-00108
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    May 21, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-33, LOT# J0406257V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434A, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS TO UNDERGO STIMULATOR REPLACEMENT FOR NORMAL DEPLETION THE DAY AFTER THE REPORT. THE PATIENT HAD NO STIMULATION SENSATION AND IT WAS UNKNOWN WHEN IT HAD BEEN LOST. WHEN IMPEDANCES WERE RUN, VALUES RANGED FROM 400-3300 OHMS AND THE ??? SCREEN WAS ALSO DISPLAYED. THE IMPEDANCES WERE NOT DONE AT HIGHER VALUES, AND THIS WAS SUGGESTED. THE FOLLOWING DAY, IMPEDANCE TESTING DONE AT HIGHER LEVELS (3.5V) REVEALED SEVERAL COMBINATIONS GREATER THAN 4000 OHMS (C/0, C/1, C/2, 0/2 AND 1/3). THE REMAINING ELECTRODES HAD IMPEDANCES RANGING FROM 826 TO 3093 OHMS. THE PATIENT WAS PROGRAMMED WITH ELECTRODES 1/3 AND WITH AMPLITUDE INCREASED TO 10V, THE PATIENT STILL DID NOT FEEL STIMULATION. THE CAUSE OF THE IMPEDANCE WAS NOT DETERMINED. THE WHOLE SYSTEM WAS REPLACED AND THE PATIENT WAS DOING WELL AS OF (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370428 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR