BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3981466 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13976
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 14, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL A WEEK PRIOR TO CALL AND THINKS THEIR DEVICE MAY HAVE BEEN KNOCKED OUT OF PLACE. IT WAS NOTED THE CORNER OF THE DEVICE WAS BULGING OUT. IT WAS REPORTED THE PATIENT HIT EVERYTHING THEY COULD WHEN THEY FELL. IT WAS NOTED THE PATIENT HAD SMALL FIBER NEUROPATHY THAT AFFECTED THEIR BALANCE. IT WAS REPORTED THE PATIENT TORE THEIR ROTATOR CUFF WHEN THEY FELL, BUT COULD NOT HAVE AN MRI DUE TO THE STIMULATOR. IT WAS REPORTED THE PATIENT DID NOT TAKE ANY ACTION ON THE ISSUE, BUT WILL CONTACT SURGEON IF IT CONTINUES TO BOTHER THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456983 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1