BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2982461 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03138
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LET THE IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETE. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE INS FOR A COUPLE OF WEEKS PRIOR TO (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN CHARGING THE INS IN THAT TIME PERIOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ADJUST THE STIMULATION. DISPLAY SHOWING "CALL YOUR DOCTOR" ICON WAS NOTED. A POWER ON RESET (POR) CONDITION WAS STATED. IT WAS ALSO STATED THAT "THIS ACTION RESOLVED THE REPORTED ISSUE." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85897 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