BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3181830 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10690
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 31, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3587A, LOT# L68514, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT HIGH IMPEDANCES OF >4000 OHMS WERE MEASURED ON THE PATIENT¿S INS AND THAT THE CAUSE WAS NOT DETERMINED. THE PATIENT WAS ADVISED TO SCHEDULE AN APPOINTMENT FOR FOLLOW-UP WITH THEIR MANAGING PHYSICIAN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW NO LIGHT NEXT TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY INDICATOR ON THE BACK OF THE PROGRAMMER. IT WAS NOTED THE PATIENT FELT NO STIMULATION ¿FOR THE PAST FEW DAYS OR SO.¿ THE PATIENT PROGRAMMER WOULD NOT SHOW A LIGHT NEXT TO THE INS BATTERY ICON BUT ONLY THE GREEN LIGHT ON THE TOP AND THE LIGHT NEXT TO THE 9V BATTERY DISPLAY. IT WAS NOTED THAT PATIENT STATED SHE WAS ¿GETTING NOTHING¿ MEANING SHE DID NOT FEEL STIMULATION. DURING THE CALL, THE PATIENT TRIED THE PATIENT PROGRAMMER AND REPORTED SEEING A GREEN AND NON-BLINKING LIGHT NEXT TO THE INS BATTERY ICON. IT WAS FURTHER REPORTED THAT THE PATIENT HAD NO SIMULATION SENSATION. THE PATIENT TRIED INCREASING STIMULATION BUT DID NOT FEEL IT. THE PATIENT STATED SHE ¿TENDS TO BE A LITTLE MORE ACTIVE NOW.¿ IT WAS NOTED THE PATIENT FIRST NOTICED NOT FEELING STIMULATION WHEN TRYING TO TURN THE INS ON ¿3 DAYS AGO.¿ IT WAS LATER REPORTED THAT WHEN THE STIMULATION WAS TURNED ON, THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THERE WERE IMPEDANCE READINGS OF GREATER THAN 4000 OHMS ON SOME OF THE BIPOLAR PAIRS. THERE WERE ALSO GREATER THAN 4000 OHMS ON ALL OR SOME OF THE UNIPOLAR PAIRS. ALL PAIRS WITH ELECTRODES 3 WERE GREATER THAN 4000. IT WAS NOTED IMPEDANCES WERE TESTED AT 3V. IT WAS NOTED THAT THEY WERE WORKING ON THE BOTTOM OF THE LEAD AS THEY WERE TRYING TO CAPTURE STIMULATION IN THE FEET AREA AND HAD BEEN USING ELECTRODES 1, 2 AND 3. IT WAS NOTED THAT WHEN THE PATIENT WAS PROGRAMMED HIGHER UP ON THE LEAD, THE PATIENT HAD SOME STIMULATION SENSATION IN THE UPPER THIGH AND SHIN, WHICH WAS NOT THE TARGET AREA. IT WAS NOTED THERE WAS NO TRAUMA AND THE PATIENT HAD LOSS OF STIMULATION THERAPY ABOUT 1 MONTH. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL PAIRS WITH ELECTRODE 2 HAD IMPEDANCE READINGS OF "???"

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ALSO REPORTED THERE WAS AN EOS EOL MESSAGE. IT WAS NOTED THERE WAS A REVISION HAPPENING AT TIME OF REPORT. IT WAS LOGGED THE INS WAS AT EOL AND 2 OF 4 CONTACTS WERE REPORTED NOT WORKING ON THE LEAD/EXT SYSTEM. IT WAS REPORTED THE HCP WAS PLANNING TO REMOVE AND REPLACE THE ENTIRE SYSTEM AND MOVE IT FROM THE PATIENT¿S ABDOMEN TO HER BACK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT ONLY HAD THE BATTERY REPLACED DUE TO NORMAL END OF LIFE. IT WAS ALSO NOTED THAT EVERYTHING WORKED FINE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281988 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 00060 YR Required Intervention