BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR MRI/SURESCAN

    MDR report key: 3800865 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08767
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED INTERMITTENT STIMULATION, LOSS OF STIMULATION/ THERAPEUTIC EFFECT, OVERSTIMULATION, AND STIMULATION IN THE WRONG LOCATION. THE DEVICE WAS REPROGRAMMED. IT WAS REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2014. LESS THAN 24 HOURS POST OP, THE PATIENT CALLED REPEATEDLY AND STATED HE FELT STIMULATION IN OTHER AREAS THAN JUST BILATERALLY FROM HIS KNEES TO HIS FEET. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE (REP) MET WITH THE PATIENT AND HIS WIFE POST OP DAY 3, WHICH WAS REPORTEDLY ¿TOO SOON TO PERFECT THE STIM.¿ AT THE PATIENT¿S REGULARLY SCHEDULED FOLLOW UP APPOINTMENT (POST OP DAY 11), THE REP WAS ABLE TO GET STIMULATION IN THE DESIRED AREAS, AND THE PATIENT WAS REPORTEDLY HAPPY. IT WAS REPORTED THE PATIENT THEN CALLED A WEEK LATER STATING HE COULD AGAIN FEEL STIMULATION IN HIS BACK AND SIDES, NOT JUST FROM THE KNEES DOWN. IT WAS REPORTED THAT THE PATIENT ¿JUMPED TO THE CONCLUSION¿ THAT SOMETHING WAS WRONG, AND INSISTED ON BEING SEEN RIGHT AWAY. IT WAS REPORTED THERE WAS AN APPOINTMENT SCHEDULED FOR THIS THURSDAY, (B)(6) 2014. THE PATIENT REPORTEDLY CALLED THE REP YESTERDAY STATING THAT THE DEVICE TURNED ITSELF UP TO THE POINT OF PAINFUL AND HE COULD BARELY GET IT TURNED OFF IN TIME. IT WAS NOTED THE REP RETURNED THE PATIENT¿S PHONE CALL AND THE PATIENT WAS REPORTEDLY ¿PESSIMISTIC, IRRATIONAL, AND CONVINCED THAT SOMETHING WAS WRONG AND ¿WAS HE THE ONLY ONE TO HAVE THESE PROBLEMS?¿¿ THE PATIENT NOTED THAT ¿IT NEVER WORKED¿ IN THE 5 WEEKS SINCE HE¿S HAD THE DEVICE. IT WAS NOTED THE PATIENT WAS ¿EXTREMELY PESSIMISTIC¿ AND EXPECTS THINGS TO BE JUST AS HIS TRIAL WAS IMMEDIATELY POST IMPLANT. IT WAS NOTED THE PATIENT EXPECTED IMMEDIATE RESULTS AND WAS NOT HAPPY WHEN THAT DIDN¿T HAPPEN. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTEDLY ASSOCIATED WITH THE EVENT. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITHOUT INJURY AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF INITIAL REPORT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CAME IN FOR AN OFFICE VISIT THE DAY OF THE CURRENT REPORT AND THE MANUFACTURER REPRESENTATIVE (REP) ATTEMPTED A REPROGRAM. IT WAS REPORTEDLY UNSUCCESSFUL ION THE RIGHT LEAD (THE PATIENT STATED IT ONLY GETS INTO SIDE, REGARDLESS OF WHERE THE REP WAS ON THE LEAD). IT WAS NOTED THE LEFT LEAD AT THE BOTTOM GOT GOOD STIMULATION, BUT WHEN THE PATIENT STOOD, STIM WENT AWAY. WHEN THE AMPLITUDE WAS INCREASED IT JUMPED INTO HIS LEFT SIDE AND HE FELT NOTHING IN HIS LEFT LEG. THE PATIENT WAS ASKED TO SIT AND THEN STIM WAS IN THE LEFT LEG LIKE IT NEEDED TO BE. X-RAYS WERE TAKEN TO RULE OUT LEAD MIGRATION AND IT WAS NOTED THE LEADS LOOKED FINE. IT WAS NOTED THE LEADS WERE ACTUALLY CLOSE TO IDENTICAL AS THE TRIAL PLACEMENT. THE PHYSICIAN WANTED THE PATIENT TO LEAVE STIM OFF FOR 1 WEEK. IT WAS NOTED THE PHYSICIAN WAS THINKING THE PATIENT NEEDED MORE TIME TO HEAL AND WAS TRYING TO DO TOO MUCH TOO SOON AND MAY HAVE SOME UNREALISTIC EXPECTATIONS THIS EARLY POST IMPLANT. IT WAS NOTED IF THE PATIENT STILL HAD ISSUES AFTER 1 WEEK WITH STIM OFF, THE PHYSICIAN WOULD CONSIDER MOVING LEADS MORE MIDLINE. THE PATIENT WAS TO COME BACK IN 1 WEEK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD RECENTLY UNDERGONE A LEAD REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL POST LEAD REVISION AND WAS GETTING OPTIMAL STIMULATION IN ALL DESIRED AREAS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DURING THE PATIENT¿S REVISION, THE ORIGINALLY IMPLANTED SYSTEM WAS KEPT INTACT. IT WAS NOTED THAT ONLY REPOSITIONING WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277177 RESTORE SENSOR MRI/SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention