BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2802601 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09454
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    April 25, 2014
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DIDN¿T UNDERSTAND WHY IT DID NOT HELP THEM. IT WAS NOTED THEY HAD TO MOVE THEIR NECK A CERTAIN WAY IN ORDER TO FEEL THE STIMULATION. IT WAS STATED ¿ALL OF A SUDDEN IT DIDN¿T WANT TO CHARGE UP.¿ IT WAS STATED IT HAD HAPPENED FOR A WHILE. IT WAS NOTED THE DOCTOR THOUGHT IT WAS THE INS AND NOT THE WAY IT WAS PLACED. IT WAS STATED THE YEAR PRIOR TO REPORT THE MANUFACTURER REPRESENTATIVE HAD THOUGHT IT WAS THE WAY IT WAS PLACED AND NOT THE INS. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT SCHEDULED 4 DAYS FOLLOWING REPORT. IT WAS STATED THE PATIENT COULD NOT CHARGE. IT WAS NOTED THAT THE PATIENT DID NOT WANT TO GO THROUGH ANOTHER SURGERY BECAUSE THE FIRST ONE HURT REALLY BAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INTERMITTENT STIMULATION FOLLOWING IMPLANT. THE PATIENT WAS WORKING WITH HIS PHYSICIAN AND A MANUFACTURER REPRESENTATIVE ON THE NEXT STEPS FOR RESOLUTION. THE PATIENT'S STIMULATION WAS SUPPOSED TO BE COVERING BOTH HIS RIGHT AND LEFT SIDES BUT IT WAS ONLY COVERING THE LEFT SIDE WHEN HE TURNED A CERTAIN WAY AND IT WAS STILL INTERMITTENT. INITIALLY THE PATIENT'S STIMULATION WORKED AS SOON AS HE TURNED HIS NECK AND HE DID NOT THINK ANYTHING OF IT BECAUSE HE FELT STIMULATION ALL THE TIME, BUT NOW HE ONLY FELT STIMULATION WHEN HE TURNED HIS NECK A CERTAIN WAY. THE PATIENT HAD NO TRAUMAS OR MEDICAL PROCEDURES THAT COULD HAVE BEEN A CONTRIBUTING FACTOR. PRIOR TO THIS REPORT THE PATIENT HAD TWO VISITS WITH MANUFACTURER REPRESENTATIVES FOR TESTING AND REPROGRAMMING BUT THE VISIT WERE UNSUCCESSFUL. IT WAS NOTED THE PATIENT STILL EXPERIENCED INTERMITTENT STIMULATION WHEN HE INCREASED HIS STIMULATION. IT WAS ALSO REPORTED WHEN THE PATIENT TURNED HIS STIMULATION 'REAL, REAL HIGH' IT CAUSED HIS LEFT LEG AND ARM TO START JERKING. THE PATIENT'S PHYSICIAN PERFORMED AN X-RAY THE WEEK PRIOR TO THIS REPORT; THE LEADS WERE SEEN BUT THE PHYSICIAN WANTED TO TALK TO A MANUFACTURER REPRESENTATIVE. THE PATIENT WAS TOLD THERE WAS POSSIBLY AND ISSUE WITH 'THE WIRES' AND HIS PHYSICIAN WANTED TO TEST THEM AGAIN. ADDITIONAL INFORMATION RECEIVED TWO WEEKS LATER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. ALL IMPEDANCES WERE WITHIN RANGE. REPROGRAMMING OCCURRED ON (B)(6) 2012, AND EVERYTHING WORKED CORRECTLY BUT THE PATIENT WAS NOT EXPERIENCING PARESTHESIA IN THE CORRECT LOCATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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