BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2870200 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11742
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), IMPLANTED: 1998 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUDDEN INCREASE IN STIMULATION AND THAT THE DEVICE HAD BEEN TURNING ITSELF ON AND OFF. IT WAS STATED THAT SINCE THE IMPLANT REPLACEMENT IN 2007, THE PATIENT "NEVER REALLY GOT GOOD PAIN RELIEF LIKE HER FIRST IMPLANT." IT WAS NOTED THAT THE IMPLANT SITE HAD BEEN HURTING FOR "OVER A YEAR," BUT THE "LAST 1-2 MONTHS" IT HAD BEEN HURTING "REALLY BAD, TO THE POINT THAT IT AFFECTED HER WALKING." THE PATIENT STATUS WAS UNKNOWN. ADDITIONAL INFORMATION HAD BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1