BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3170271 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10388
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 23, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3986, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 7492, SERIAL# (B)(4), IMPLANTED: (B)(6) 1989, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND ACUTE PAIN IN THE LEFT HIP WHICH STARTED ABOUT SIX DAYS AGO. HE HAD AN MRI ABOUT ONE MONTH AGO DUE TO PAIN IN HIS LEFT HIP. HIS HEALTH CARE PROVIDER WAS TRYING TO FIGURE OUT THE CAUSE OF IT. HIS DEVICE WAS STILL WORKING AT THAT TIME. HE DID TRY TO INCREASE AND DECREASE STIMULATION BUT NOTHING HAS SEEMED TO HELP. HIS DEVICE THERAPY NORMALLY REALLY HELPS HIM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT'S IMPLANTABLE DEVICE WAS NOT WORKING. WHEN TURNING ON THE PATIENT PROGRAMMER IT WAS REPORTED THAT ALL "FOUR LIGHTS WERE ON" AND NONE OF THEM WERE BLINKING. TROUBLESHOOTING WAS DONE, PROGRAMMER WAS TURNED ON AGAIN AND "THERE WAS A BEEP." IT WAS REPORTED THAT ALL FOUR LIGHTS WERE STILL ON. IT WAS REPORTED THAT PATIENT WAS NOT FEELING ANY STIMULATION. IT WAS REPORTED THAT THE STIMULATION STOPPED SIX DAYS AGO. IT WAS REPORTED THAT IT WAS POSSIBLE THAT THE PATIENT HAD GOTTEN WATER ON THE PATIENT PROGRAMMER. IT WAS REPORTED THAT THE PATIENT HAD AN MRI DONE ABOUT A MONTH AGO FOR LEFT HIP PAIN. IT WAS REPORTED THAT THE STIM HAD BEEN ON BUT IT WASN'T REALLY HELPING THE PATIENT ABOUT A MONTH AGO. IT WAS REPORTED THAT THE PATIENT FELT THAT THE PAIN HAD GOTTEN WORSE SINCE THE MRI. IT WAS REPORTED THAT NORMALLY THE DEVICE WORKS FOR THE PATIENT AND IT HELPED THE PATIENT A LOT. PATIENT HAD TRIED ADJUSTING STIM BUT IT WASN'T WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270842 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 00083 YR