BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4233313 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21110
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 20, 2014
    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: 3550-39, LOT# N286061, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37092, LOT# 282480001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT ONE MONTH PRIOR TO THE CALL, THE PATIENT WOULD TURN THEIR STIMULATION OFF PRIOR TO CHARGING. AFTER CHARGING, THE PATIENT USED THE PATIENT PROGRAMMER TO TURN THE NEUROSTIMULATOR BACK ON AND RECEIVED A ZAP/JOLTING SENSATION. THE PATIENT ALSO REPORTED THE SAME ZAP/JOLTING SENSATION THROUGHOUT THE DAY, AND COULD NOT ASSOCIATE ANY ACTIVITIES THAT MIGHT HAVE CAUSED IT. IMPEDANCES TESTS WERE PERFORMED AND WERE WITHIN NORMAL LIMITS. THERE WERE NO MESSAGES SEEN ON THE PATIENT OR CLINICIAN PROGRAMMERS. BESIDES THE ZAP/JOLTING SENSATION, THE PATIENT REPORTED APPROPRIATE STIMULATION COVERAGE. ADDITIONAL INFORMATION REPORTED THAT THE CAUSE WAS NEVER DETERMINED, BUT THE PATIENT WAS RECEIVING THERAPY. THE HAD NOT CONTACTED THE MANUFACTURER REPRESENTATIVE ABOUT FURTHER JOLTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713809 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 00062 YR