BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2974015 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02981
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3986A, LOT# N306389, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE NEEDED A RESET. THE DEVICE WAS CLEARED USING THE CLINICIAN PROGRAMMER. NO DATA WAS LOST. THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT ADJUST STIMULATION. THE PATIENT WAS ABLE TO TURN STIMULATION ON/OFF WITH THE RECHARGER. AN 'IN THE BOX' ICON WAS DISPLAYED. AN INTERROGATION OF THE DEVICE USING A CLINICIAN PROGRAMMER WAS SCHEDULED TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77740 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