BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3272762 · Received August 8, 2013

    Report

    Report Number
    3004209178-2013-13007
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Report Date
    July 15, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3487A-45 LOT# V191419, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-45 LOT# V191307, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708220, SERIAL# (B)(4); IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT WAS GETTING A SHOCKING SENSATION WHEN THE PATIENT BENT OR STRETCHED TO PUT SOMETHING AWAY. IT WAS NOTED THAT THIS STARTED TWO WEEKS AGO. IT WAS NOTED THAT THIS HAPPENED WHEN THE DEVICE WAS ON AND THE PATIENT HAD NOT TURNED OFF THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT WAS IN AN ACCIDENT TWO MONTHS PRIOR TO REPORTING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THE DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. IT WAS NOTED THAT THE PATIENT DID NOT HAVE HEALTH INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374945 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 00056 YR