BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2875308 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11894
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 29, 2012
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37083-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A25, LOT# N171817, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT# N266246, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD TWO DIATHERMY PROCEDURES DONE ON (B)(6) 2012. IT WAS STATED THAT THE PATIENT NOTICED AN INCREASE IN PAIN AFTER THE FIRST PROCEDURE. IT WAS NOTED THAT THE STIMULATOR WAS NOT AS EFFECTIVE. REPROGRAMMING WAS DONE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO ADVERSE EVENT. ABOUT TWO WEEKS LATER IT WAS REPORTED THAT DIATHERMY WAS NOT USED. IT WAS REPORTED THAT THE PATIENT ACTUALLY HAD A STANDARD ULTRA SOUND. THERE WAS NO MORE CONCERN THAT DIATHERMY WAS USED, BUT THE DEVICE WILL STILL BE INTERROGATED. THERE WERE NO MALFUNCTIONS SEEN. THE LEVEL OF EFFECTIVE THERAPY WAS UNKNOWN AT THE TIME AND THE PATIENT WAS GOING TO BE SEEN IN THE CLINIC ON (B)(6) 2012. ABOUT ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC. REPROGRAMMING OF THE DEVICE WAS DONE, AND IT WAS DETERMINED THAT THE DEVICE WAS FUNCTIONING PROPERLY. IT WAS STATED THAT THE PATIENT WAS RECEIVING BETTER PARESTHESIA COVERAGE. IT WAS STATED THAT NO FURTHER STEPS WERE GOING TO BE TAKEN. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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