BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3132344 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08215
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    October 29, 2012
    Report Date
    May 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: RECHARGER: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND ¿PULSING¿ SENSATION FROM THEIR IMPLANTABLE NEURO STIMULATOR (INS) AFTER A FALL ON (B)(6) 2012 IN WHICH THEY LANDED ON THEIR RIGHT SIDE (WHERE THE INS WAS LOCATED). IT WAS REPORTED THAT THE PATIENT ONLY USED THE STIMULATION ¿AS NEEDED¿. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RARELY USED THE STIMULATION THERAPY. IT WAS NOTED THAT AFTER THE PREVIOUSLY REPORTED FALL, THE PATIENT TURNED THE INS ON TO HELP WITH THE RESULTING PAIN. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS REPORTED AS NO INJURY, NO ADVERSE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING STIMULATION TO ALL AREAS OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235371 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 00072 YR