BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4746575 · Received May 4, 2015

    Report

    Report Number
    3004209178-2015-08424
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Report Date
    April 29, 2015
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID 3550-29, LOT# N142181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3888-28, LOT# L35222, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER'S REPRESENTATIVE (REP). AN APPOINTMENT WAS SCHEDULED FOR 5/15 WITH THEIR PHYSICIAN. IT WAS NOTED THE PATIENT HAD RECENTLY E-MAILED THE MANUFACTURER'S REPRESENTATIVE (REP) ABOUT POSSIBLY FINDING A PHYSICIAN IN THE AREA THAT MIGHT BE ABLE TO REPLACE HER DEVICE. ANOTHER REP. SPOKE WITH THE PATIENT RECENTLY WHO NOTED THAT THE PATIENT WAS GOING BACK TO SEE HER NEUROSURGEON FOR AN OPINION ON IF SHE NEEDED A DIFFERENT SURGERY OR JUST NEEDED THE STIMULATOR REPLACED. THE PATIENT WAS GOING TO CONTACT THE REP. AFTER THAT APPOINTMENT. THE REP. HAD NOT MET WITH THE PATIENT OR CHECKED HER DEVICE AND HAD NOT WORKED WITH THE PATIENT'S NEUROSURGEON VERY MUCH BUT HE PRACTICED AT NORTHWEST HOSPITAL IN SEATTLE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT W ILL BE SENT.

    Description of Event or Problem · 1

    NO STIMULATION SENSATION WAS REPORTED. THE PATIENT BELIEVED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAS REACHED END OF SERVICE (EOS). EVENTUALLY IT JUST STOPPED WORKING. THE PATIENT¿S PREVIOUS HEALTH CARE PROVIDER (HCP) RETIRED SO SHE NEEDS TO FINE A NEW HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT IF ANY INTERVENTION OR TROUBLESHOOTING WAS REQUIRED AND TO OBTAIN THE OUTCOME OF THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291103 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR