BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3112457 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07663
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3550-39 LOT# N317046, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT THEIR DEVICE WAS NOT FUNCTIONING CORRECTLY BECAUSE WHEN THE PATIENT "WAS IN THE SAME POSITION" THE PATIENT EXPERIENCED "A SUDDEN SURGE WITH STIMULATION." IT WAS NOTED THAT THE PATIENT "GOT TO" A "COMFORTABLE" SETTING ON GROUP A AND THEN "STAYED THERE FOR 3 MINUTES" WHICH THEY THOUGHT RESOLVED THE ISSUE. IT WAS FURTHER NOTED, THE PATIENT CALLED BACK "A FEW MINUTES LATER" AND REPORTED THE SAME ISSUE. IT WAS NOTED DEVICE TROUBLESHOOTING WAS CONSIDERED. IT WAS FURTHER NOTED, THE PATIENT WAS ON GROUP B IN MANUAL MODE AND DID NOT EXPERIENCE ISSUES. IT WAS NOTED A TIME WOULD BE IDENTIFIED TO COMPLETE A "REPROGRAMMING CHECK." IT WAS FURTHER NOTED, THE PREVIOUS TIME THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT, ALL IMPEDANCES CHECKED OUT NORMAL AND THE SYSTEM WAS INTACT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO DIAGNOSTICS PERFORMED ON THE DEVICE. IT WAS NOTED THAT THERE WERE NO MALFUNCTIONS OR CAUSES OF ISSUE DETERMINED. IT WAS FURTHER NOTED THE STIMULATION SETTINGS WERE "RESET." IT WAS NOTED THAT IT WAS UNKNOWN IF THE PATIENT RECEIVED EFFECTIVE THERAPY. IT WAS FURTHER NOTED THAT PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212964 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1