BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2920638 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00722
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V011515, IMPLANTED: (B)(4) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAD WIRE STICKING OUT IN HER BACK, BUT IT HAD NOT BROKEN THROUGH THE SKIN. THE REPORTER STATED THAT IT HAD BEEN STICKING OUT OF THE PATIENT'S BACK FOR THE LAST SIX MONTHS BEFORE THE REPORT. IT WAS REPORTED THAT IT WAS HARD FOR THE PATIENT TO WALK OR BEND OVER FOR THE LAST WEEK OR TWO PRIOR TO THE REPORT. THE REPORTER STATED THAT STIMULATION WAS INTERMITTENT AND WAS "ON AND OFF." IT WAS REPORTED THAT EVEN WHEN THE PATIENT COULD FEEL THE STIMULATION, SHE WAS NOT GETTING PAIN RELIEF. IT WAS NOTED THAT STIMULATION HAD BEEN INTERMITTENT SINCE THE LEAD WIRE MOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THE DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25652 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1