BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2876248 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11940
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 26, 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

    PRODUCT ID 399945, LOT # V028473, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT COULD NOT FEEL A STIMULATION SENSATION. THE PATIENT COULD NOT RECALL WHEN THEY LOST STIMULATION. IT WAS STATED THAT THE PATIENT LAST RECHARGED THE IMPLANTABLE NEUROSTIMULATOR (INS) A MONTH AGO. THE PATIENT WAS UNABLE TO USE THE PROGRAMMER TO COMMUNICATE WITH THE INS. IT WAS NOTED THAT THERE WERE NEW BATTERIES IN THE PROGRAMMER. IT WAS REPORTED THAT THE PATIENT WAS SEEING A QUESTION MARK ON THE SCREEN OF THE PROGRAMMER. ONE DAY LATER IT WAS REPORTED THAT THE #8 ELECTRODE WAS SHOWING AN IMPEDANCE VALUE OF OVER 10,000 OHMS. ALL OTHER ELECTRODES WERE "NORMAL" WITH IMPEDANCE VALUES BETWEEN 800-900 OHMS. IT WAS REPORTED THAT THE PATIENT WAS GETTING "GOOD" STIMULATION AND COULD FEEL STIMULATION. THE PATIENT WAS NOT PROGRAMMED ON ELECTRODE #8. THE REASON FOR #8 BEING OPEN WAS UNKNOWN. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1