BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2831918 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10251
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, LOT# VA02AUM015, 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. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE REPROGRAMMED THE PATIENT AND WAS STILL ATTEMPTING TO T ROUBLESHOOT THE DEVICE. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "SURGING" SENSATION WHEN TRANSITIONING FROM LYING ON HER RIGHT SIDE TO AN UPRIGHT POSITION WHILE ADAPTIVE STIMULATION WAS ACTIVATED. WHEN THE ADAPTIVE STIMULATION WAS OFF AND THE PATIENT PERFORMED THE SAME POSITIONAL TRANSITIONS, NO "SURGING" OCCURRED. THE PROBLEM WAS THAT THE VOLTAGE OUTPUT FOR SOME POSITIONAL CHANGES WAS NOT CHANGING CORRECTLY. THE PATIENT WAS IN AN UPRIGHT POSITION, BUT WAS RECEIVING THE VOLTAGE FOR LYING ON HER RIGHT SIDE. THEY TRIED ALLOWING TIME BETWEEN POSITIONAL CHANGES, BUT THE STIMULATION DID NOT CHANGE CORRECTLY. THE PATIENT WAS REPROGRAMMED SUCH THAT THE VOLTAGE FOR LYING ON EITHER OF HER SIDES WAS THE SAME AS AN UPRIGHT POSITION TO PREVENT THE "SURGING" SENSATION. THE PATIENT'S STATUS WAS REPORTED AS "FAIR." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD REORIENTED THE PATIENT'S SENSOR THREE TIMES. THE "SURGING" SENSATION EVEN OCCURRED WHILE IN THE TEST ADAPTIVE STIMULATION MODE. THE REPROGRAMMING WAS CONSIDERED A "TEMPORARY FIX.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MEDTRONIC REPRESENTATIVE SAW THE PATIENT AT THE CLINIC AND THE SITUATION WAS STILL UNRESOLVED. THE PATIENT WAS STILL GETTING TWICE THE AMPLITUDE WHEN GOING FROM LYING DOWN TO THE UPRIGHT POSITION; EVEN WHEN THE PATIENT STAYED IN THE POSITION FOR TWO MINUTES, THE AMPLITUDE WAS STILL TWICE AS MUCH. IT WAS NOTED THAT THIS HAPPENED EVERY TIME THE PATIENT GOES FROM LYING TO UPRIGHT. IT WAS STATED THAT STIMULATION WAS TURNED OFF. IT WAS ALSO STATED THAT THE PATIENT WAS PROGRAMMING THEIR DEVICE MANUALLY. IT WAS NOT CLEAR IF ALL STIMULATION WAS TURNED OFF, OR JUST THE ADAPTIVE STIMULATION. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS STILL EXPERIENCING THE SAME 'SURGING' SENSATION THAT WAS PREVIOUSLY REPORTED. TROUBLESHOOTING WAS BEING CONDUCTED TO SOLVE THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00058 YR