BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3943486 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13214
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 27, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PATIENT HAD NEVER EXPERIENCED THIS FEELING BEFORE. THE PATIENT FELT STIMULATION FROM OUTSIDE AND THOUGHT THEY WERE CRAZY. THE PATIENT¿S SPOUSE FELT THE IMPULSE ON THE PATIENT TOO. IT ZAPPED THE PATIENT AND HIT A ¿WEIRD¿ NERVE. THE PATIENT CONFIRMED THAT THEY FELT A SHOCKING SENSATION. THE SHOCKING STARTED A WEEK OR TWO PRIOR TO THE REPORT AND HAD NEVER HAPPENED BEFORE THAT. THE SHOCKING HAPPENED WHEN THE PATIENT MOVED A CERTAIN WAY. DURING THE REPORT THE PATIENT FELT THE SHOCKING AGAIN AND NOTED THAT IT MOVED AND HIT THEM NEAR THEIR COLLAR BONE WHICH WAS A DIFFERENT SPOT THAN BEFORE. THE PATIENT FELT THE SHOCKING AT NIGHT WITH THE STIMULATION OFF AS WELL. THE PATIENT HAD A FALL A MONTH OR SO PRIOR TO THE REPORT BUT THEY DID NOT HURT THEIR ARM. AFTER THE FALL THE PATIENT¿S KNEE WAS MESSED UP. THE PATIENT HAD ALSO LOST 55 POUNDS BETWEEN DECEMBER AND THE TIME OF THE REPORT. THE PATIENT WAS WONDERING IF THE WEIGHT LOSS COULD HAVE AFFECTED THE STIMULATION AND CAUSED THE SHOCKING SENSATION. THE STIMULATOR ITSELF FELT TIGHTER. BEFORE THEY LOST WEIGHT THE STIMULATOR MOVED AROUND MORE. THE PATIENT NOTICED THAT IT FELT TIGHTER ABOUT 2-3 WEEKS PRIOR TO THE REPORT. THE PATIENT THOUGHT THAT THE CHANGE WAS BECAUSE THEY HAD LOST WEIGHT AND WERE MOVING AROUND MORE AND STRENGTHENING. THE THERAPY HELPED THE PATIENT. AFTER THEY BECAME ACCUSTOMED TO THE STIMULATION THEY LOST WEIGHT AND GAINED STRENGTH. THE PATIENT ALSO HAD A CAT SCAN ON THEIR KNEE. THE PATIENT MENTIONED THAT IT TOOK THEM A LITTLE TIME TO GET THEIR STIMULATION TO THE PROPER SETTING AND THAT THEY HAD TO RUN STIMULATION HIGHER SOMETIMES. THE PATIENT WAS GOING TO SCHEDULE AN APPOINTMENT WITH THEIR SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD LOST WEIGHT AND AROUND THE SAME TIME THEY WERE ZAPPING THEIR WIFE THROUGH THE IMPLANT. THE PATIENT WAS REPROGRAMMED BY THE MANUFACTURER REPRESENTATIVE (REP) AND IT HAD BEEN OKAY SINCE THEN. THEY LOST WEIGHT AND WERE ZAPPING THEIR WIFE IN 2014, AND THAT WAS ALSO WHEN REPROGRAMMING WAS DONE. THE PATIENT HADN'T HAD TO SEE ANYONE FOR FOLLOW-UP EXCEPT FOR ONE INSTANCE OF REPROGRAMMING IN 2014 WHERE THEY SAW A MANUFACTURER REPRESENTATIVE (REP). INFORMATION REGARDING IF THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422677 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