BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2933712 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01088
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 15, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-9, LOT# N274336, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3550-29, LOT# N203697, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS 'HURTING REAL BAD' THE MORNING OF THE REPORT. THE REPORTER STATED THAT THE PATIENT WAS GIVEN MORE PROGRAMS AND WHILE TRYING TO FIND OUT WHICH PROGRAM WAS HELPING, HE THOUGHT HE TURNED SOMETHING OFF. THE PATIENT WAS INITIALLY AT PROGRAM 1 A AT 3.0 VOLTS AND STIMULATION WAS ON. THE PATIENT CHANGED PROGRAMS AND SETTINGS. IT WAS UNCLEAR WHICH PROGRAM THE PATIENT WAS ON AND IT WAS REPORTED THAT PROGRAM 1 WAS STILL AT 3.0 VOLTS. IT WAS REPORTED THAT STIMULATION WAS NOT WORKING LIKE THE PATIENT WAS TOLD IT WOULD. THE REPORTER STATED THAT A MANUFACTURER REPRESENTATIVE TOLD THE PATIENT THAT HIS PAIN WAS TOO HIGH FOR THE THERAPY. IT WAS REPORTED THAT THE LEADS AND DEVICE WERE BETWEEN THE SPINE AND LEFT SHOULDER BLADE AND THE PATIENT STATED THAT THERE WAS A LOT OF MOVEMENT. IT WAS UNCLEAR IF THIS REFERRED TO PATIENT MOVEMENT OR DEVICE MOVEMENT. THE REPORTER STATED THAT THE DEVICE WAS JUST ABOVE THE BELT LINE ON THE LEFT SIDE, AND THE PATIENT WAS TOLD IT WOULD TAKE CARE OF 80% OF THE PAIN. IT WAS NOTED THAT THE DEVICE DID HELP 'SOME.' IT WAS REPORTED THAT THE PATIENT'S DOCTOR HAD SAID THAT THE LEADS NEEDED TO BE FASTED TO THE SPINE, BUT THE PATIENT WASN'T READY FOR THAT. THE REPORTER STATED THAT THE PERCENTAGE OF PAIN RELIEF DEPENDED ON THE PATIENT'S POSITION. WHEN THE PATIENT WAS ON THE COUCH WITH A PILLOW BEHIND HIS BACK THE DEVICE HELPED WITH 70% OF THE PAIN. IT WAS REPORTED THAT IF THE PATIENT WAS UP 'IT WAS ALMOST NOTHING.'

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS ONLY ABLE TO FEEL STIMULATION WHEN HE WAS 'IN AN AWKWARD POSITION.' IT WAS STATED THAT 'IF THE PATIENT IS SHOCK IN THE RIGHT PLACE HE WILL FEEL THAT.' IT WAS ALSO STATED THAT 'THE PATIENT WAS SHOCK WHERE HE NEEDED IT AND THAT IS WHEN HE GOT IN CONVERSATION WITH REP (COMPANY REPRESENTATIVE) ABOUT INFORMATION IN HIS MIND.' IT WAS NOT CLEAR IF THOSE STATEMENTS MEANT THE PATIENT WAS GETTING STIMULATION OR A SHOCKING SENSATION. IT WAS ALSO UNCLEAR WHAT EXACTLY 'INFORMATION IN HIS MIND' MEANT. IT WAS STATED THAT 'NOTHING HAS BEEN DONE' SINCE THE PATIENT WAS TOLD HIS DEVICE MOVED. BY 'DEVICE' IT WAS UNCLEAR IF THE REPORTER MEANT THE IMPLANTABLE NEUROSTIMULATOR (INS) OR LEAD. THE LEAD WAS REPLACED ON (B)(6) 2012. THE PATIENT FELT PAIN ON HIS LEFT SIDE AND 'DEVICE GOING UP THE LEFT SIDE CROSSED TO THE RIGHT SIDE.' IT WAS UNCLEAR IF THE PATIENT HAD PAIN ALL THE WAY UP HIS LEFT SIDE, OR IF THAT'S WHERE HIS LEAD WAS. THE PATIENT THOUGHT THE DEVICE WAS IN THE 'WRONG PLACE.' IT WAS REPORTED THAT THE PATIENT WAS FRUSTRATED BECAUSE HE WAS TOLD THE DEVICE WOULD TAKE CARE OF 80% OF HIS PAIN, BUT 'IT DOESN'T WORK.' FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT # 3004209178-2012-03269.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39252 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