BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3221388 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11632
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 24, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008: PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008: PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008: PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008: PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND LANDED ON THEIR BUTTOCKS. THERE WAS AN UNDESIRABLE CHANGE IN STIMULATION. THE PATIENT NO LONGER FELT STIMULATION IN THE AREA OF HER PAIN. IT WAS NOTED THE DEVICE WAS CUTTING ON AND OFF ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320093 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR