BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3929102 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12885
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 19, 2014
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3487A-33, LOT# V072248, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXT ENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE HAD NOTICED THAT ONCE OR TWICE, THE DEVICE CAME ON BY ITSELF WHEN SHE WAS SITTING IN A WOODEN CHAIR. THIS WAS NOTED TO HAVE HAPPENED AROUND (B)(6) 2013, NOT LONG AFTER THE PATIENT GOT HER DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOTICED SOME DIFFERENCES BETWEEN THEIR CURRENT SYSTEM AND THEIR PREVIOUS SYSTEM AND THEY PREFERRED THEIR PREVIOUS SYSTEM. THE PATIENT NOTICED SOME CHANGES IN THEIR STIMULATION INTENSITY WHEN THEY CHANGED POSTURE. THEY HAD INCREASES IN INTENSITY, MOSTLY AT NIGHT WHEN THEY WERE SLEEPING. SOMETIMES THE STIMULATION WOULD SEEM FINE FOR 2-3 DAYS AND THEN FOR SOME REASON IT WOULD ACT UP. THE STIMULATION ALSO SEEMED WEAKER WHEN THE BATTERY WAS LOW. THE PATIENT FELT LIKE THE SYSTEM TOOK A LOT OF WORK AND DIDN¿T SEEM WORTH IT. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT LIKE THE UNEXPECTED CHANGES IN FREQUENCY OF THEIR DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407872 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