BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2839302 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10534
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 22, 2012
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3986A, LOT# N191031, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3986A, LOT# N191031, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED, THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2012. IT WAS UNCLEAR WHETHER THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR THERAPY OR DEVICE AND WHETHER OR NOT THEY HAD SOUGHT FURTHER HELP. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING A "BURNING FEELING" WHEN RECHARGING AROUND THE POCKET AREA. HOWEVER, THE PATIENT ALSO STATED THERE WAS A "WARM SENSATION" IN OR AROUND THE DEVICE POCKET DURING CHARGING. IT IS UNCLEAR WHICH REPORT WAS A MORE ACCURATE DESCRIPTION OF THE ISSUE. THE AREA WAS RED AND WARM TO THE TOUCH THEN WENT AWAY. THE PATIENT NOTICED THE CHANGE ABOUT "ONE YEAR AGO." BEFORE THE ISSUE THE PATIENT'S RECHARGING SESSIONS WERE ABOUT "THREE HOURS LONG" AND AFTER THEY WERE "SIX HOURS LONG" AND THE "PAIN AND BURNING" WAS WORSE. THE PATIENT CHARGED WITH HER HEAD IN HER JEANS WHILE SITTING UP. OTHER TIMES THERE WAS PAIN AROUND THE POCKET, DEPENDENT ON THE PATIENT'S MOVEMENT AND ACTIVITY. THE PATIENT ALSO REPORTED THAT THE DEVICE MOVED "SOME" UNDER THE POCKET. THE PATIENT DESCRIBED HERSELF AS "BONY." THE PATIENT HAD TRIED ADDING A LAYER OF INSULATION BETWEEN THE ANTENNA AND SKIN, BUT SHE JUST GOT HOTTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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