BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 2871900 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11799
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 15, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT COULD STILL FEEL STIMULATION WHEN THE DEVICE WAS TURNED OFF. IT WAS NOTED THAT THIS SENSATION BEGAN APPROXIMATELY ONE WEEK PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT TOOK A COUPLE OF FALLS AND HER DOCTOR KNEW ABOUT THEM. IT WAS REPORTED THAT THE DOCTOR TOLD THE PATIENT THAT THE TIPS OF THE DEVICE SYSTEM WIRES ON TOP WERE 'BENT A LITTLE.' AT THE TIME OF THE REPORT THE REPORTER STATED THAT THE PATIENT TURNED THE DEVICE OFF AND DID NOT FEEL STIMULATION. THE PATIENT THEN BENT OVER TO SEE IF SHE COULD FEEL THE STIMULATION BECAUSE 'THAT WAS WHEN SHE WOULD FEEL IT.' IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL THE STIMULATION EVEN WHEN SHE BENT OVER WITH THE DEVICE OFF. FIVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS OFF BUT SHE STILL FELT STIMULATION LIKE THE DEVICE WAS ON. THE REPORTER STATED THAT THE STIMULATION FEELING WAS ON THE RIGHT SIDE ONLY. IT WAS NOTED THAT THE PATIENT PROGRAMMER SHOWED THAT THE DEVICE WAS IN OFF MODE. IT WAS REPORTED THAT THE PATIENT HAD SHUT HER DEVICE OFF THE PREVIOUS DAY. THE REPORTER STATED THAT THIS HAD BEEN GOING OFF AND ON NOW FOR ABOUT A MONTH. IT WAS UNCLEAR WHEN THE SENSATION ACTUALLY STARTED. IT WAS NOTED THAT THE PATIENT HAD FALLEN TWICE AND IT SEEMED THAT THIS STARTED AFTER THAT. IT WAS REPORTED THAT THERE WAS AN X-RAY OF THE LEADS AND THEY 'SEEMED TO LOOK OK.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1