BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3103115 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07462
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 4, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE RECEIVED ASSISTANCE FROM THEIR DOCTOR AND MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT WAS ¿VERY HAPPY¿ AT THIS TIME. FURTHER FOLLOW UP INFORMATION RECEIVED 12 DAYS LATER FROM THE HEALTHCARE PROFESSIONAL (HCP) CONFIRMED THAT THE MANUFACTURER¿S REPRESENTATIVE REPROGRAMMED THE PATIENT. THE HCP CALLED THE PATIENT AND THE REPRESENTATIVE DID SOME CHANGES WITH THE STIMULATOR AND WAS ¿WAITING IT OUT¿ TO SEE HOW THE CHANGES WORK. HOSPITALIZATION WAS NOT REQUIRED FOR THE EVENT AND THE OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT ¿NEVER¿ HAD THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT DID NOT HAVE PAIN RELIEF AND HAD ¿A COUPLE¿ REPROGRAMMING SESSIONS. THE PATIENT REPORTEDLY HAD PAIN AT THE POCKET SITE, WHICH HAD BEEN SORE SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT RECEIVED A TOPICAL TREATMENT AFTER INCISION SITE HEALED, BUT IT ¿DID NOT HELP.¿ THE PATIENT REPORTEDLY KEPT ¿BUMPING INTO THINGS¿ WHICH CAUSED THE POCKET SITE TO BE ¿CONSTANTLY IRRITATED.¿ IT WAS NOTED THAT THE PATIENT WANTED THE DEVICE REMOVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT HAD DIFFICULTY USING THE PROGRAMMER TO MAKE ADJUSTMENTS. THE PATIENT STATED HIS POCKET WAS "HUGE" AND "STICKS OUT" AND WAS PAINFUL TO TOUCH. THE PATIENT HAD ACUTE PAIN AT THE POCKET SITE AS WELL. THE PATIENT HAD BUMPED IT ON A SLIDING GLASS DOOR 3 DAYS PRIOR. THE INABILITY TO ADJUST STIMULATION MAY HAVE BEEN DUE TO POCKET SWELLING. THE PATIENT HAD SEEN HIS PHYSICIAN SEVERAL TIMES AND NOTHING HAD BEEN DONE. THE PATIENT FELT THE DEVICE WAS "TOO BIG" AND HE COULD FEEL RIDGES IN IT, AND FELT IT WAS ALMOST AS BIG AS THE PROGRAMMER. THE PATIENT ALSO REPORTED A LOSS OF THERAPEUTIC EFFECT, DESPITE REPROGRAMMING AFTER IMPLANT. THE PATIENT FELT AS IF HIS STIMULATOR WAS MALFUNCTIONING. THE PATIENT EXPERIENCED A SHOCKING SENSATION THAT FELT LIKE HE WAS GETTING "PUNCHED IN THE STOMACH" WHEN THERAPY WAS TURNED ON. THE PATIENT GOT A JOLT EVERY TIME HE TURNED THERAPY ON. THE PATIENT FELT THIS JOLT EVEN IF HE HAD TURNED STIMULATION DOWN PRIOR TO TURNING IT OFF AND TITRATING UP AFTER TURNING IT BACK ON. THE PATIENT ALSO NOTED ISSUES WITH HICCUPS, SHALLOW BREATHING, RESPIRATORY PROBLEMS AND DROWSINESS. THE PATIENT WAS EXPLORING THE OPTION OF EXPLANTING THE STIMULATOR AND HAVING A PAIN PUMP IMPLANTED INSTEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HAVING THE DEVICE REMOVED. IT WAS FURTHER CLARIFIED THAT THE PATIENT HAD AN APPOINTMENT (B)(6) 2013 FOR EITHER AN EXPLANT OR A REPROGRAMMING SESSION. THE STIMULATION WASN'T DOING ANYTHING FOR HIM. THE PATIENT WAS UNABLE TO WALK. THE PATIENT STATED THAT HIS HCP DIDNT THINK THEY WENT "DEEP ENOUGH" WITH THE UNIT OR DIDNT USE THE RIGHT UNIT. THE PATIENT STATED IT FELT LIKE A BEE WAS STINGING HIM ALL THE TIME, WHICH HAD BEEN PRESENT SINCE IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY HAD A UNIT PUT IN AND THE LOCATION OF THE BATTERY WAS HORRIBLE; IT CAUSED SO MUCH PAIN AND WAS NOT BENEFITING THE PATIENT. THE PATIENT WANTED TO FIND A NEW DOCTOR THAT WOULD ACCEPT HIS INSURANCE AND REMOVE THE UNIT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THERE WAS NO STIMULATION DAILY AND THE THERAPY WAS NOT HELPING AT ALL. IT WAS NOT WORKING RIGHT SINCE IMPLANT AND THE PATIENT HAD NOT CHARGED IT IN A COUPLE OF MONTHS OR LONGER. A WEEK AFTER IMPLANT, THEY HAD BEEN ADJUSTING IT, BUT IT HAD NOT BEEN WORKING RIGHT. THE PATIENT WANTED THE DEVICE REMOVED. IF THE PATIENT TRIED TO CHARGE IT, IT WOULD HIT HIM FOR A COUPLE OF SECONDS AND THEN IT WOULD CHARGE UP. IT WAS NOTED THE IMPLANT WAS RIGHT WHERE THE PATIENT'S BELT WAS SO HE COULD NOT WEAR PANTS.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT HAD NOT BEEN SEEN BY THE HEALTHCARE PROFESSIONAL (HCP) SINCE (B)(6) 2012 AND NO DOCUMENTATION OF THE REPORTED SYMPTOMS WERE FOUND ON THE PATIENT¿S CHART. THE PATIENT¿S NEXT APPOINTMENT WAS SCHEDULED FOR LATE (B)(6) [2013]. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT HAD CONCERNS WITH THEIR DEVICE OR THERAPY AT THE TIME OF FOLLOW-UP. IT WAS STATED THE PATIENT WAS WORKING WITH THEIR PHYSICIAN REGARDING THEIR CONCERNS AND THE PHYSICIAN WAS "TREATING THE PATIENT'S PROBLEM IN THE WRONG MANNER." THE PATIENT NOTED "THIS IS NOT THE MEDICAL PROBLEM I HAVE," HOWEVER, IT WAS NOT APPARENT AT THE TIME OF FOLLOW-UP WHAT EXACT CONDITION THE PATIENT WAS REFERRING TO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT REPORTED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT SINCE (B)(6) 2013 THE PATIENT HAD BEEN THINKING ABOUT HAVING THE THERAPY REMOVED BECAUSE IT WAS NOT HELPING WITH HIS PAIN. IT WAS NOTED THAT THE PATIENT STATED THAT INITIALLY WHEN HE WAS IMPLANTED IT DID PROVIDE SOME RELIEF. IT WAS NOTED THAT THE TRIAL ALSO WORKED FOR HIS PAIN. IT WAS NOTED THAT THE PATIENT STATED THAT HE HAD BEEN IN FOR MANY ADJUSTMENTS BUT IT HAD GOTTEN TO THE POINT THAT HE JUST DOESN'T WANT TO TRY ANY MORE. IT WAS NOTED THAT THE PATIENT STATED THAT HE TURNED HIS STIMULATOR OFF 2 WEEKS PRIOR TO REPORT AND THE PATIENT COULD NOT REMEMBER THE LAST TIME HE RECHARGED IT. IT WAS NOTED THAT THE PATIENT STATED THAT IT WAS DISAPPOINTING BECAUSE HE WAS STILL MAKING PAYMENTS FOR THE DEVICE. IT WAS NOTED THAT THE PATIENT STATED THAT HE WAS BACK TO TAKING ORAL PAIN MEDICATION THAT HE WAS TAKING BEFORE THE STIMULATION IMPLANT. IT WAS NOTED THAT THE PATIENT FELT LIKE HE WAS BACK TO SQUARE ONE. IT WAS NOTED THAT SINCE THE IMPLANT THE PATIENT'S INS POSITION HAD BEEN UNCOMFORTABLE. IT WAS NOTED THAT IT WAS ON HIS LEFT SIDE RIGHT AT HIS BELT LINE. IT WAS NOTED THAT THE PATIENT COULD NOT WEAR HIS BACK BRACE. IT WAS NOTED THAT THE PATIENT COULD HARDLY WEAR A BELT WITH HIS PANTS. IT WAS NOTED THAT THE PATIENT STATED THAT WHEN HE SAT DOWN THE INS STUCK OUT AND IT WAS PAINFUL. IT WAS NOTED THAT THE PATIENT STATED THAT HIS DOCTOR TOLD HIM IT COULD BE MOVED BUT THE PATIENT STATED THAT THE THERAPY WAS NOT WORKING FOR HIM ANYWAY SO HE DIDN'T WANT TO HAVE SURGERY TO MOVE THE DEVICE IF IT WASN'T EVEN WORKING FOR HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204436 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 00056 YR