BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3870727 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11521
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# V741237, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V745830, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT# V766316, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM WHEN THE PATIENT WOULD TRY TO USE HER RECHARGER. IT WAS STATED THAT THE PATIENT¿S DEVICE WOULD SHUT OFF AND SHE COULD NOT GET IT TO TURN BACK ON. IT WAS STATED THAT WHEN THE PATIENT WOULD TRY TO CHARGE HER BATTERY SHE WOULD GET THE ¿REPOSITION ANTENNA¿ SCREEN. IT WAS NOTED THAT ON THE DAY OF THIS REPORT, THE PATIENT DIDN¿T ¿FEEL STIMULATION NOW, BUT DID EARLIER.¿ IT WAS STATED THAT THE PATIENT HAD BEEN DIAGNOSED WITH ¿CRPS¿ AND THAT HER STIMULATOR WOULD INTERFERE WITH IT. IT WAS NOTED THAT THE PATIENT HAD HER STIMULATOR ON, ON THE DAY OF THIS REPORT. IT WAS STATED THAT THE PATIENT¿S INS HAD LAST BEEN RECHARGED ¿ABOUT A MONTH OR SO AGO.¿ IT WAS NOTED THAT THE PATIENT COULD NOT CONNECT TO HER INS WITH HER PATIENT PROGRAMMER (PP) EITHER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT WAS STILL WAITING FOR THEIR APPOINTMENT TO BE SCHEDULE WITH THE DOCTOR AND THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348389 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 00029 YR