BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 2900066 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00247
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 18, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THERE WERE TIMES WHEN STIMULATION WAS OFF BUT IT FELT LIKE IT WAS ON. FOR ABOUT AN HOUR AFTER THE PATIENT TURNED STIMULATION OFF, SHE FELT STIMULATION WHICH HURT HER LEGS AND FEET AND SHE COULDN'T KEEP THEM STILL. THIS WAS DESCRIBED AS A SHOCKING SENSATION. THE REPORTER ALSO STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) MADE A "BUZZING" SOUND WHICH LASTED 20-30 SECONDS. THIS WAS REPORTED TO HAVE HAPPENED 3 TIMES; THE FIRST ON (B)(6) 2012 AND THE THIRD, BED TIME THE FOLLOWING DAY. THERE WAS NO UNCOMFORTABLE STIMULATION DURING THE "BUZZING" SOUND. THE REPORTER STATED THAT THE PATIENT SAW HER HEALTHCARE PROVIDER (HCP) ON (B)(6) 2012 AND HAD AN APPOINTMENT IN 3 MONTHS WITH A MEDTRONIC REPRESENTATIVE TO HAVE THE DEVICE CHECKED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS UNCLEAR IF THE PATIENT STILL HAD CONCERNS WITH HER DEVICE/THERAPY OR IF SHE HAD SOUGHT HELP WITH REGARDS TO HER CONCERNS. IT WAS INDICATED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. AFTER THE PATIENT TURNED HER DEVICE OFF AT NIGHT, SOMETIMES HER NERVE OR MUSCLE HURT. IT WAS ALSO NOTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER HEALTHCARE PROVIDER (HCP) OR MEDTRONIC REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. IT WAS FURTHER INDICATED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT WAS WORKING WITH HER HCP OR MEDTRONIC REPRESENTATIVE. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT STILL HAD CONCERNS WITH HER DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. IF ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7033 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