BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2834514 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10341
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377660, LOT# V012086, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377660, LOT# V012086, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS ABOUT HIS DEVICE OR THERAPY. IT WAS REPORTED THAT THE PATIENT HAS APPOINTMENTS ON (B)(6) 2012 AND (B)(6) 2012 TO MEET WITH THEIR PHYSICIAN OR MEDTRONIC REPRESENTATIVE. FURTHER INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE STIMULATOR WAS "NOT WORKING WELL." IT WAS STATED, THE PATIENT WAS SEEN ON (B)(6) 2012 AND AN X-RAY SHOWED THAT THE LEADS "SEEMED TO HAVE MIGRATED." IMPEDANCES WERE CHECKED AND WERE FOUND TO BE "EXTREMELY HIGH." NO HOSPITALIZATION WAS REPORTED DUE TO THIS EVENT. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INTERMITTENT STIMULATION SINCE (B)(6) 2012. STIMULATION HAD NOT TURNED ON FOR ABOUT A WEEK, BUT IT HAD BEEN TURNING ON AND OFF PRIOR TO THAT. IT WAS INDICATED THAT THE DEVICE ONLY HELPED TO RELIEVE PAIN DURING THE SUMMER. IN THE WINTER THE PATIENT'S LEGS "GOT BAD AND TURNED BLUE." IT WAS MENTIONED THAT THE PATIENT HAD EXPERIENCED MORE LEG PAIN SINCE RIDING THEIR BIKE ABOUT A MONTH AGO. IT WAS STATED THAT THE PATIENT MAY HAVE HAD A "DETACHED MUSCLE OR A BLOOD CLOT." A TWO INCH BUMP WAS ALSO REPORTED IN THE "AREA." IT WAS UNCLEAR EXACTLY WHAT THAT AREA WAS. FURTHER INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    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