BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3051421 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05949
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 25, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A-56, LOT# V273078, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-56, LOT# V196169, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT CONFIRMED SHE RECEIVED ASSISTANCE AND FELT HER CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS RESET AND WAS WORKING "PERFECTLY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PROGRAMMER DISPLAYED THE POOR COMMUNICATION SCREEN. THE PATIENT HAD A WARNING POWER ON RESET (POR). THE PATIENT HAD TURNED THE STIMULATOR ON 4 DAYS PRIOR AND HAD CHARGED THE WEEKEND PRIOR. THE PATIENT ALSO HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT THE STIMULATION WASN'T AS STRONG AS SHE WAS SETTING IT FOR. ON (B)(6) 2013, THE STIMULATOR WENT DEAD. IT WAS FURTHER REPORTED THAT WHEN A COMPANY REPRESENTATIVE TRIED TO CHARGE THE STIMULATOR, ANOTHER POR WAS SEEN. THE DEVICE WAS DISCHARGED. AFTER THE POR MESSAGE, THE NORMAL RECHARGING SCREEN WITH 8 COUPLING BOXES WAS NOTED. THE POR MESSAGE APPEARED SEVERAL TIMES WHILE THE PATIENT WAS CHARGING. OF NOTE, THE PATIENT HAD A TUMOR REMOVED FROM HER ABDOMEN 2 WEEKS AGO, BUT THIS WAS AFTER THE INITIAL POR WAS SEEN. THE PATIENT HAD PET SCANS AS WELL AS CHEMOTHERAPY, BUT NO MRIS OR RADIATION. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT TURN STIMULATION BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149921 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 00054 YR