BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2990251 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03338
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3888-45, LOT# VA02NL8, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3888-45, LOT# VA02NL8, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 377745, LOT# V004789, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: RECHARGER: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 355029, LOT# N094910, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: ACCESSORY: PRODUCT ID 355029, LOT# N079830, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT IT WAS "GETTING A LITTLE BIT HARDER TO WALK" FOR THE PATIENT. IT WAS REPORTED THAT THE DEVICE "STOPPED WORKING. IT WAS REPORTED THAT AS OF THE DAY OF REPORT THE DEVICE WAS "ABSOLUTELY DOING NOTHING. ADDITIONAL INFORMATION: IT WAS REPORTED THAT "THEY THINK THE LEAD TO THAT DEVICE HAS FRACTURED, BUT NO WAY OF KNOWING FOR SURE UNTIL THEY GET IN THERE." IT WAS REPORTED THAT THE PATIENT WAS HAVING "SEVERE PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO STIMULATION SENSATION WAS FELT BY THE PATIENT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THIS CHANGE WAS FIRST NOTED ON TWO DAYS PRIOR TO THE REPORT. THE AMPLITUDE WAS INCREASED AND THE PATIENT CHANGED POSTURES BUT STILL DID NOT FEEL THE STIMULATION. THE LOCATION OF THE PATIENT'S SYMPTOMS WAS IN HER LEGS. IT WAS THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) COULD BE OFF. IT WAS ALSO STATED THAT THE PATIENT WAS DIAGNOSED WITH HEPATITIS A AND WAS UNDER CARE OF HER PHYSICIAN. THE PATIENT USED PROGRAM GROUP B AT 5.40 V. WHEN SHE SWITCHED THE GROUP, THE PATIENT INCREASED THE AMPLITUDE "ALL THE WAY PAST 7 V" AND STILL HAD NO STIMULATION. THE AMPLITUDE WAS THEN LOWERED BACK DOWN TO 5.4 V. MORE THAN TWO WEEKS LATER IT WAS REPORTED THAT THREE DAYS AGO IN THE EVENING AND THEN THE NEXT MORNING THE PATIENT WAS HAVING EXTREME PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93608 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 00061 YR