BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3926587 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12809
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 18, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION. IT WAS REPORTED WHEN THE PATIENT WOULD GO THROUGH THE (B)(6) SECURITY GATES, SHE WOULD GET SHOCKED. IT WAS NOTED THIS OCCURRED 2 YEARS AGO IN 2012. IT WAS NOTED THE STIMULATION WAS NOT ON DURING THE GATE ENCOUNTER. IT WAS REPORTED THE DEVICE QUIT WORKING ALMOST 2 YEARS AGO. THE PATIENT MOVED OUT OF (B)(6) IN 2011 TO (B)(6) , AND THE DEVICE WORKED 5 MONTHS AFTER MOVING AND THEN QUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403716 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR