BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3071100 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06657
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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 THE STIMULATION WAS "FLUTTERING" AND WOULD GO OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT LIKE STIMULATION WOULD GO "HAYWIRE" WHEN THEY WOULD CHANGE POSITIONS. IT WAS STATED THAT THE STIMULATION WAS NOT "ADAPTING" TO CHANGES IN POSITION. IT WAS NOTED THAT THE PATIENT FELT AS THOUGH STIMULATION WOULD "GO OFF" WHEN THEY WERE NO CHANGING POSITIONS. IT WAS NOT RELATED TO ANY SPECIFIC POSITIONS. IT WAS REPORTED THAT THIS BEGAN AFTER THE PATIENT WAS IN A CAR ACCIDENT ON (B)(6) 2012. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN CHECKED IN (B)(6) 2012 AND "EVERYTHING WAS NORMAL AND THE PATIENT WAS GETTING THE COVERAGE SHE NEEDED". IT WAS NOTED THAT THE PATIENT HAD ONE PROGRAM USING ELECTRODES 4, 5, AND 6. A SECOND PROGRAM USED ELECTRODES, 5, 6 AND 7. IT WAS STATED THAT ALL COMBINATIONS USING ELECTRODES 7,8, 9, 10, 13, 14, AND 15 HAD IMPEDANCES GREATER THAN 40,000 OHMS. IT WAS ALSO REPORTED THAT WHEN THE PATIENT FELT STIMULATION "GO HAYWIRE" THE PROGRAMMER WAS NOT SHOWING THE CORRECT POSITIONS. THE CLINICIAN PROGRAMMER DID SHOW ALL THE CORRECT POSITIONS. THE COMPANY REPRESENTATIVE DID NOT RE-ORIENT THE INS, BUT ADJUSTED THE VOLTAGE FOR DIFFERENT POSITIONS. IT WAS STATED THAT THERE WAS NO CHANGE IN THE INS POSITION IN THE ABDOMEN DUE TO THE CAR ACCIDENT. CYCLING WAS NOT ON. IT WAS STATED THAT PRIOR TO ENDING CHARGING THE PATIENT WOULD MAKE SURE THE INS WAS ON, AND WHEN THEY WOULD CHECK IT AFTER CHARGING IT WOULD SAY THE INS WAS OFF. THE PATIENT STATED THAT THEY WERE NOT USING THE ON/OFF BUTTONS. IT WAS ALSO NOTED THAT THE PATIENT HAS TO CHARGE MORE FREQUENTLY NOW. IT WAS STATE THAT SINCE THE PATIENT'S CAR ACCIDENT THE DEVICE HAS NOT WORKED "RIGHT". THE PATIENT HAD TWO LEADS. ON ONE LEAD, ALL OF THE ELECTRODES HAD OUT OF RANGE IMPEDANCES. THE SECOND LEAD HAD ONLY ONE OUT OR RANGE ELECTRODE. THE COMPANY REPRESENTATIVE WAS ABLE TO PROGRAM AROUND THE OUT OF RANGE ELECTRODES. IT WAS STATED THAT THE COVERAGE WAS NOT AS GOOD, BUT THE PATIENT WANTED TO TRY THIS BEFORE ANY SORT OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171561 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 Required Intervention