BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3066752 · Received April 18, 2013

    Report

    Report Number
    3004209178-2013-06526
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Report Date
    April 2, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION SENSATION. IT WAS HOWEVER UNCLEAR WHEN THE PATIENT STOPPED FEELING STIMULATION. AT THE TIME OF THE REPORT, THE PATIENT INCREASED STIMULATION PAST 8 V BUT STILL DID NOT FEEL STIMULATION. THE PATIENT REPORTEDLY HAD PAIN IN HER HIP, KNEE AND LEG. THE REPORTER INDICATED THAT THERE WAS NO KNOWN ACCIDENT RELATED TO THIS. IT WAS LATER CONFIRMED THAT STIMULATION WAS ON AND THE PATIENT'S PROGRAM WAS SWITCHED BUT STILL COULD NOT FEEL STIMULATION. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER HEALTHCARE PROVIDER THE FOLLOWING DAY. THE FOLLOWING DAY, IT WAS REPORTED THAT REPROGRAMMING WAS ATTEMPTED BUT THE PATIENT COULD STILL NOT FEEL STIMULATION. IT WAS NOT POSSIBLE TO TURN STIMULATION UP FOR THE PATIENT TO FEEL. IMPEDANCES ON CONTACTS 1 AND 4 WERE GREATER THAN 10,000 OHMS. THE PATIENT WAS REPROGRAMMED NOT USING CONTACT 1 AS BOTH OF HER PREVIOUS EXISTING GROUPS WERE USING THAT CONTACT. STIMULATION WAS SUBSEQUENTLY PROVIDED IN THE REQUESTED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167170 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1