BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3912524 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12496
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N313968, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CT SCAN TYPE MYELOGRAM PERFORMED THE DAY PRIOR TO THE REPORT WITH A SPINAL INJECTION UNDER FLUOROSCOPY AND SOMEHOW IT CHANGED THEIR STIMULATOR. THE DEVICE WAS PROGRAMMED TO TARGET THEIR LUMBAR AND LOWER BACK AND SINCE THE MYELOGRAM THEY COULD FEEL IT IN THEIR UPPER CHEST. THE PATIENT DID NOT TURN THEIR STIMULATION DOWN TO 0V AND OFF BEFORE THE SCAN. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT WAS SCHEDULED TO MEET A MANUFACTURER REPRESENTATIVE ON (B)(6) 2014 FOR REPROGRAMMING. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390326 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 00037 YR