BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2841829 · Received November 21, 2012

    Report

    Report Number
    1030489-2012-02423
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 26, 2012
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3986ILC, LOT# N26493, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A RETURN OF PAIN SYMPTOMS IN THE OCCIPITAL AREA BEHIND THE RIGHT EAR WHERE THE IMPLANT IS. THE PAIN VARIED AND WAS MORE TOLERABLE WITH THEIR HEAD FORWARD. THE PAIN WAS MORE SEVERE WITH WHEN THEY TURNED TO THE RIGHT OR LEFT, MOST SEVERE WHEN THEY TURNED THEIR HEAD TO THE EXTREME RIGHT. STIMULATION WAS INCREASED TO "12 CLICKS" WHICH WAS HIGHER THAN NORMAL. THE CHANGE IN EFFECT HAS BEEN NOTICED SINCE (B)(6) 2012. THERE WAS NO TRAUMA ASSOCIATED WITH THE EVENT, BUT THE PATIENT HAD EMOTIONAL STRESS DUE TO THE RECENT DEATH OF THEIR SON. THERE WAS ALSO A LIGHT BLINKING ON THE PATIENT PROGRAMMER THAT INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS LOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00077 YR Required Intervention