BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3162638 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10147
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 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 STIMULATION IN THE WRONG LOCATION BECAUSE THE DEVICE WAS "NOT PROGRAMMED RIGHT." THE PATIENT FELT STIMULATION ON THE RIGHT SIDE OF HER STOMACH AND RIGHT HIP. HER PAIN WAS ACROSS HER LOW BACK JUST BELOW HER WAIST LINE. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) AND WAS TESTED IN SURGERY AND FELT STIMULATION ON BOTH HER LEFT AND RIGHT SIDE, BUT NOW SHE WAS ONLY FEELING STIMULATION ON HER RIGHT SIDE. THE PATIENT WAS REPROGRAMMED ON (B)(6) FOR 2 HOURS WITHOUT SUCCESS. DURING THE REPROGRAMMING SESSION THE MANUFACTURER REPRESENTATIVE TURNED STIMULATION UP TOO HIGH AND THE PATIENT FELT LIKE SHE WAS GETTING ELECTROCUTED. THE PATIENT WAS REPROGRAMMED AGAIN ON (B)(6) WITHOUT SUCCESS. IT WAS REPORTED THAT THE PATIENT COULDN¿T HAVE STIMULATION ON BECAUSE OF THE WAY IT WAS PROGRAMMED IT HURT TO BEND. IT WAS NOTED THAT BEFORE SCS THE PATIENT ONLY HAD TO USE A WALKER WHEN SHE LEFT THE HOUSE, BUT FOLLOWING THE PROCEDURE SHE HAD TO USE THE WALKER BOTH WHEN SHE WAS AT HOME AND WHEN SHE WENT OUT. IT WAS ALSO REPORTED THAT THE PATIENT WAS SWELLING MORE THAN NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCE MEASUREMENTS WERE PERFORMED AND CHECKED OUT FINE. THE PATIENT¿S DEVICE WAS REPROGRAMMED AND THEY WERE ABLE TO GET STIMULATION IN SOME OF HER PAIN AREAS. IT WAS NOTED THERE WERE NO MALFUNCTIONS AND NO KNOWN INTERVENTIONS. IT WAS UNKNOWN IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262923 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 00068 YR