BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2936076 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01153
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT COULDN'T CHARGE HIS DEVICE AND HAD COUPLING OR COMMUNICATION ISSUES. THE REPORTER STATED THAT THE PATIENT STILL HAD STIMULATION BUT HE HAD TURNED IT WAY DOWN. IT WAS NOTED THAT THE DEVICE BATTERY WAS LOW AND NEEDED TO BE RECHARGED. IT WAS REPORTED THAT THE RECHARGER CHARGING SESSION WAS WORKING PROPERLY AND THE REGULAR CHARGING SCREEN SHOWED ON THE RECHARGER, BUT THERE WERE 0 COUPLING BARS. IT WAS NOTED THAT THE DEVICE WAS IN THE PATIENT'S BACK AND IT WAS "REALLY HARD" FOR HIM TO REACH IT. THE PATIENT WAS GOING TO TRY TO ADJUST THE ANTENNA DIAL WITH THE ASSISTANCE OF SOMEONE ELSE. IT WAS FURTHER REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND A SYMPTOM INCLUDED ACUTE PAIN. THE PAIN OCCURRED ABOUT 2-3 MONTHS AGO. IT WAS REPORTED THAT THE PATIENT WENT IN TO HAVE HIS DEVICE REPROGRAMMED AND HE THOUGHT SOMETHING MIGHT HAVE BEEN CHANGED. THE REPORTER STATED THAT THE PATIENT USED TO HAVE IT PROGRAMMED SO THAT STIMULATION WOULD TURN OFF WHEN HE LAY DOWN, BUT NOW IT DIDN¿T TURN OFF AUTOMATICALLY. IT WAS REPORTED THAT IT WAS REALLY HARD FOR THE PATIENT TO GET OUT OF BED WHEN HE LEFT STIMULATION ON ALL NIGHT. IT WAS NOTED THAT THE PATIENT FELT PAIN IN HIS BACK AREA AND HE REALIZED IT AFTER HE WAS REPROGRAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41400 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