BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3102618 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07434
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 17, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WENT TO CHARGE THIS MORNING AND A POWER ON RESET (POR) DISPLAYED. THE INS STILL HAD A HALF BATTERY AND HE DOES NOT LET IT GO LOW. THE BATTERY HAS NEVER HAS BEEN BELOW HALF. HE FELT STIMULATION BUT HAS NOT TURNED HIS DEVICE ON YET WHILE CHARGING TODAY. HE HAS NOT HAD ANY MEDICAL APPOINTMENTS OR BEEN AROUND HIGH EMI SOURCES. HE WAS NOT ABLE TO ADJUST STIMULATION WITH HIS PATIENT PROGRAMMER. IT WAS LATER REPORTED THAT HE DID NOT VISIT HIS DOCTOR REGARDING THIS EVENT. THE ISSUES WERE RESOLVED BY CLEARING THE POR. IT WAS NOTED THAT THE INS BOTHERS HIS BACK. HE DIDN'T HAVE BACK PROBLEMS UNTIL HE HAD THE ORIGINAL DEVICE IMPLANTED WHICH HE HAS HAD SINCE. HE HAS CONSTANT BACK PAIN AT THE LEAD SITE. THE DEVICE WORKS GREAT FOR HIS KNEES BUT HIS BACK WAS ALWAYS "KILLING HIM". PRIOR TO THIS DEVICE BEING IMPLANTED HE HAS THREE KNOTS IN HIS BACK. ONE OF THE KNOTS HAS GONE AWAY AND ONE HAS GOTTEN SMALLER. HIS INS WAS IMPLANTED AT THE RIGHT SIDE OF HIS BELLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION WITH HIS PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT SAW A CIRCLE WITH A LINE "THROUGH THE MIDDLE" ON THE PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203339 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