BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3002082 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03644
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 25, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED NOTING AN APPOINTMENT DATE LAST MONTH. IT WAS NOTED THAT THE PATIENT HAD NUMBNESS, PAIN, AND ITCHING ON THE LEFT SIDE, AS WELL AS HAVING SOME PAIN THAT THE DEVICE DID NOT HELP WITH, BUT OVERALL THE PATIENT WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A WEEK PRIOR THE REPORT THE PATIENT BEGAN RECEIVING STIMULATION IN THE WRONG LOCATION. THE PATIENT REPORTED THAT HER LEFT DEVICE WAS IMPLANTED FOR HER LEGS AND THAT 'IT' GOT STUCK ON HER BONE. THE PATIENT REPORTED THAT SHE HAD PAIN IN HER LEG AND THE NIGHT BEFORE THE REPORT IT WAS VERY BAD AND WAS DESCRIBED AS RESTLESS LEG SYNDROME THAT WENT UP INTO HER ARM. THE PATIENT WANTED THE LEFT DEVICE REPROGRAMMED. THE PATIENT ALSO STATED THAT HER LEAD ON THE RIGHT SIDE APPEARED TO HAVE GOTTEN CLOSER TO THE SURFACE IN THE MIDDLE OF HER BACK AND THIS CONCERNED HER. LATER THAT DAY IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD MET THE PATIENT SEVERAL TIMES AND INTENDED TO DO SO AGAIN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #3004209178-2013-03642. IT WAS UNKNOWN WHICH DEVICE WAS ON THE LEFT AND WHICH WAS ON THE RIGHT, ALONG WITH THE ASSOCIATED LEADS.

    Description of Event or Problem · 1

    THE CALLER REPORTS STIMULATION IN THE WRONG LOCATION. BEGAN OCCURRING ABOUT A WEEK AGO. CALLER REPORTS THAT SHE HAS PAIN IN HER LEG. CALLER REPORTS THAT LEFT INS IS IMPLANTED FOR HER LEGS AND THAT IT GETS STUCK ON HER BONE. PT REPORTS THAT SHE HAD A REVISION ABOUT 2 MONTHS AGO TO MOVE INS LOCATION, BUT IT IS STILL GIVING HER ISSUES. CALLER REPORTS THAT LAST NIGHT HER LEG PAIN WAS VERY BAD DESCRIBED AS RESTLESS LEG SYNDROME THAT WENT UP INTO HER ARM. CALLER WOULD LIKE TO SEE IF THE LEFT INS CAN BE RE-PROGRAMMED. CALLER REPORTS THAT HER LEAD ON THE RIGHT SIDE APPEARS TO BE GETTING CLOSER TO THE SURFACE IN THE MIDDLE OF YOUR BACK THIS IS CONCERNING TO HER DUE TO A PREVIOUS EXPERIENCE THAT SHE HAD WITH A WIRE THAT BECAME INFECTED AND ERODED THROUGH THE SKIN. WE HAVE MET WITH HER SEVERAL TIMES. WILL DO SO AGAIN. PATIENT INDICATED ¿NOT GETTING ADEQUATE COVERAGE ON HER LEFT SIDE.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED NOTING AN APPOINTMENT DATE LAST MONTH. IT WAS NOTED THAT THE PATIENT HAD NUMBNESS, PAIN, AND ITCHING ON THE LEFT SIDE, AS WELL AS HAVING SOME PAIN THAT THE DEVICE DID NOT HELP WITH, BUT OVERALL THE PATIENT WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105396 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1