BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2834351 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10336
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 3778-60, SERIAL#: (B)(4), 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: 3550-39, LOT#: N266529, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A "SURGE" SENSATION AND A CHANGE IN STIMULATION SENSATION WITHOUT ADJUSTING THE PATIENT PROGRAMMER. IT WAS STATED THAT THE STIMULATION WAS SET ON A CERTAIN SETTING AND "SPIKED UP" FIFTEEN TO TWENTY MINUTES LATER. THE PATIENT REPORTEDLY FELT THE STIMULATION INCREASE, SAW IT ON THE SCREEN, AND HAD TO TURN IT BACK DOWN. IT WAS NOTED THAT THE PATIENT HAD THE ADAPTIVE STIMULATION FEATURE ENABLED, BUT "IT DID NOT DO THIS BEFORE". THE PATIENT REPORTEDLY TOOK A WALK FOR MORE THAN 3 MINUTES AND THE DEVICE CHANGED TO A "HIGHER" SETTING "AT LEAST 3 TIMES". IT WAS NOTED THAT THE PATIENT NOTICED THIS FOR THE FIRST TIME LAST WEEK "ONCE OR TWICE" WHEN SHE WAS GETTING IN AND OUT OF THE CAR. THE ADAPTIVE STIMULATION FEATURE WAS DISABLED. IT WAS STATED THAT THE PATIENT HAD THE ADAPTIVE STIMULATION FEATURE FOR STANDING, SITTING, AND LYING DOWN AND "WAS NOT HAVING ANY PROBLEMS." IT WAS STATED THAT THE PATIENT FELT A "SURGE FOR A MINUTE OR TWO AND THEN IT CAME DOWN AUTOMATICALLY". IT WAS NOTED THAT THE PATIENT DECREASED THE STIMULATION WHEN THE DEVICE "SURGED". ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    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