BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3102947 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07454
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A CT SCAN "A FEW WEEKS" AGO. WHEN THE PATIENT WAS ATTEMPTING TO GET ON THE TABLE FOR THE SCAN, THE PATIENT HEARD A "POP" IN THE BACK AREA. THE PATIENT DID NOT FEEL STIMULATION AFTER THE INCIDENT. IMPEDANCE TESTING WAS DONE. AT FIRST THE IMPEDANCES WERE "XXX" FOR MOST COMBINATIONS. THEN THE IMPEDANCES WERE TESTED AT 3V. THEN IT WAS STATED THAT "ALL IMPEDANCE MEASUREMENTS WERE NO W SHOWING WITHIN NORMAL RANGE". IT WAS NOT CLEAR WHAT THIS MEANT. IT WAS STATED THAT THE PATIENT'S STIMULATION WAS OFF. THEN THE STIMULATION WAS TURNED ON, THE PATIENT WAS FEELING STIMULATION APPROPRIATELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT DID NOT HAVE THEIR STIMULATION TURNED ON. THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT AND INSTRUCTED THE PATIENT ON HOW TO USE THE PROGRAMMER AGAIN. THE REPRESENTATIVE BELIEVED THAT THE PATIENT HAD A BETTER UNDERSTANDING OF ITS USE FOLLOWING THE MEETING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204375 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