BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2874376 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11868
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT # N281935, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO RECHARGE EITHER OF HER IMPLANTS. THE REPORTER STATED THAT THE LAST TIME SHE HAD SUCCESSFULLY RECHARGED OR FELT STIMULATION WAS APPROXIMATELY 2 MONTHS AGO. IT WAS STATED THAT THE PATIENT REPORTED FEELING BETTER AND DID NOT RECHARGE THE DEVICES. THE USE OF ANTENNA LOCATE FEATURE RESULTED IN A POWER ON RESET (POR) BEING DISPLAYED ON THE RECHARGER. IT WAS STATED THAT NORMAL RECHARGING WAS POSSIBLE AFTER THE POR WAS CLEARED. IT WAS NOTED THAT THE PATIENT HAS TWO DEVICES AND WAS CURRENTLY CHARGING ONE SIDE. IT WAS REPORTED 2 DAYS LATER THAT THE PATIENT WAS GETTING THE POR ERROR WITH THE TRIANGLE ON HER PROGRAMMER. IT WAS NOTED THAT WHEN THE PATIENT REFERRED TO THE PROGRAMMER, SHE WAS TALKING ABOUT THE RECHARGER (CALLED IT THE ANTENNA). THE POR WAS CLEARED ON THE RECHARGER. IT WAS REPORTED LATER THAT DAY THAT THE PATIENT WAS NOT BEING ABLE TO ADJUST STIMULATION. THE REPORTER WAS ABLE TO CLEAR THE POR ON THE FIRST DEVICE. THE DEVICE WAS TURNED ON AND THE PATIENT WAS ABLE TO FEEL STIMULATION IN HER BACK. IT WAS LATER STATED THAT THE PATIENT SHOULD RECHARGE THE SECOND DEVICE. THE REPORTER STATED THAT THERE WAS A "CALL YOU DOCTOR" ICON ON THE PATIENT PROGRAMMER AND WAS GETTING A POR ERROR ON THE RECHARGER FOR HER DEVICE. IT WAS STATED THAT THE PATIENT'S DEVICE WAS ONE-THIRDS FULL, BUT WAS UNABLE TO USE THE PATIENT PROGRAMMER TO TURN ON THE DEVICE; WAS GETTING THE POOR COMMUNICATION SCREEN. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR REPRESENTATIVE VIA THE PHONE AND THEIR CONCERNS WERE RESOLVED. NO FURTHER INFORMATION WAS REPORTED.

    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