BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 4232854 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21085
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# J0455297V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    UPON DEVICE RETURN, ANALYSIS FOUND THE BATTERY CONTACT WAS CORRODED; THE KEYBOARD, BOTTOM CASE, GASKET, AND BATTERY COVER WERE DIRTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER (PP) WAS NOT WORKING. ONLY THE 9V BATTERY LIGHT WAS ON. THE PATIENT CHANGED THE 9V BATTERY 4 TIMES. THE PATIENT TOOK THE 9V BATTERY OUT, PUSHED AND RELEASED ALL THE BUTTONS, AND THEN PUT THE BATTERY BACK IN. ALL THE LIGHTS FLASHED AND THEN WENT OFF. THE PATIENT PLACED THE PP OVER HER IMPLANT AND PRESSED THE STIMULATION ON BUTTON. THE ONLY LIGHT WAS THE 9V BATTERY LIGHT. THIS WAS TRIED TWICE WITH THE SAME RESULTS. IT WAS ALSO NOTED THAT THE PATIENT¿S STIMULATION WAS GOING ¿CRAZY.¿ EVERY TIME SHE MOVED HER STIMULATION WOULD SPIKE. THIS STARTED IN THE MORNING OF THE DAY OF THE REPORT. A REPLACEMENT WAS SENT TO THE PATIENT THE NEXT DAY, BUT THE PATIENT WAS GOING TO GO CRAZY IF SHE HAD TO WAIT UNTIL THE NEXT DAY. IT WAS SUGGESTED THAT SHE CALL HER HEALTHCARE PROVIDER (HCP) TO SEE IF THEY COULD ASSIST. THE PATIENT RECEIVED THE REPLACEMENT PP THE NEXT DAY, BUT IT WAS NOT WORKING EITHER. THE LIGHTS WOULD ALL GO ON WHEN SHE PLACED IN THE BATTERIES AND THEN THE BATTERY LIGHT WOULD GO OUT. SHE WAS ADVISED TO HAVE HER IMPLANT CHECKED BY HER HCP. IT WAS NOTED THAT THE PATIENT DID NOT SHOW UP AT THE APPOINTMENT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713481 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 00054 YR