BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3111678 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07628
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 25, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. IT WAS STATED THE PATIENT FELT HER STIMULATION "SURGE" OR STOP ON OCCASION, USUALLY WHILE SHE WAS AT WORK. IT WAS NOTED THAT IT WOULD HAPPEN IN VARIOUS POSITIONS (SITTING, STANDING, WALKING) AND AFTER A FEW MINUTES IT TURNED BACK ON. IT WAS ALSO STATED THE PATIENT DIDN'T THINK IT WAS ASSOCIATED WITH TRANSITIONS FROM ONE POSITION TO ANOTHER, AND THAT THE STIMULATION WAS SET PRETTY HIGH AT WORK TO THE POINT WHERE IT CAN BE HARD FOR HER TO WALK WHEN SHE FIRST WOULD GET UP TO WALK. IT WAS ALSO NOTED THE PATIENT WOULD USUALLY TURN STIMULATION DOWN IN THE AFTERNOONS AS SHE WAS PREPARING TO LEAVE WORK. IT WAS STATED THE PATIENT PLANNED TO TURN STIMULATION OFF FOR DRIVE HOME, THEN TURN IT ON WHEN SHE GOT HOME. REPORTEDLY, THE PATIENT SETS THE STIMULATION ON LOWER LEVEL WHEN SHE WENT TO BED, THEN WHEN SHE WOKE UP THE STIMULATION WAS BACK AT THE HIGHER SETTING THAT SHE USED FOR WORK. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213394 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