BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2991619 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03409
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    October 3, 2011
    Report Date
    February 19, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3587A25, LOT# N279946, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELT A BURNING AND SHOCKING OR JOLTING SENSATION WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON OR OFF. THE BURNING AND SHOCKING SENSATIONS WERE FELT AT THE INS POCKET IN THE "FLANK" AREA. IT WAS STATED THAT THERE WAS NO ACCIDENT OR INCIDENT RELATED TO THE EVENT. IT WAS REPORTED THAT THIS HAS BEEN HAPPENING SINCE IMPLANTATION AND IT OCCURS RANDOMLY. IT WAS STATED THAT THE PATIENT WOULD FEEL THESE SENSATIONS "JUST SITTING IN A CHAIR". IT WAS NOTED THAT THE INS WAS NOT FLIPPED. THE PATIENT DOES NOT FEEL BURNING OR JOLTING SENSATION WHEN HE RECHARGES, BUT HAD NOTICE THE "TEMPERATURE" ICON ON THE RECHARGER. IT WAS REPORTED THAT THE PATIENT DOES FEEL SHOCKING AND BURNING WHEN HE USES THE PATIENT PROGRAMMER. IT WAS ALSO STATED THAT THE PATIENT MAY BE GETTING "SOME POSITIONAL STIMULATION CHANGES" AS WELL. THE IMPEDANCES WERE ALL WITHIN NORMAL LIMITS, 900-1100 OHMS. LATER THAT DAY IT WAS REPORTED THAT THE PATIENT WAS ADVISED THAT HE COULD HAVE THE INS MOVED TO HIS OTHER SIDE, BUT THE PATIENT SAID THAT "HE COULD LIVE WITH IT". IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. TWO DAYS LATER IT WAS REPORTED THAT NO INTERVENTIONS WERE TAKEN OR PLANNED. THERE WAS NO DEVICE MALFUNCTIONS SEEN, AND TESTING WAS DONE. IT WAS STATED THAT THE PATIENT WAS FEELING STIMULATION WHERE HE NEEDED IT, AND STILL FELT THE BURNING SENSATION RANDOMLY. THE PATIENT DECIDED NOT TO MOVE FORWARD WITH MORE DIAGNOSTICS AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT FELT THEIR STIMULATION COME ON AND OFF. IT WAS REPORTED THIS WAS ¿MORE OF A POSITIONAL THING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94837 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 00043 YR