BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 4919398 · Received July 16, 2015

    Report

    Report Number
    6000032-2015-00131
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 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 PRODUCTS: PRODUCT ID: 389033, LOT# J0320212V, IMPLANTED: (B)(6) 2003-06-20, PRODUCT TYPE: LEAD. PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE TESTING OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM FOUND IMPEDANCES OF >4000 OHMS ON UNIPOLAR ELECTRODES 2 AND 3 AND BIPOLAR ELECTRODE PAIRS 0-2, 0-3, AND 1-3. IT WAS ALSO REPORTED THE PATIENT¿S THERAPEUTIC IMPEDANCE WAS MEASURED AS >4000 OHMS. THE PATIENT ¿HAD NO SYMPTOMS ASSOCIATED WITH THE IMPEDANCES¿ AND NO CAUSE OF THE ISSUE HAD BEEN DETERMINED. THE PATIENT WAS TO BE SCHEDULED TO HAVE THEIR ENTIRE SYSTEM REPLACED AS A RESULT OF THE EVENT, THOUGH THE DATE OF SURGERY HAD NOT YET BEEN DETERMINED AS OF FOUR DAYS AFTER INITIAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462503 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 00051 YR Required Intervention