BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4243667 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21330
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 16, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW HIS HEALTH CARE PROFESSIONAL THE OTHER DAY TO SEE IF HE SHOULD HAVE HIS IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. THE INS WAS NOT WORKING TO HELP HIS PAIN AND THAT IT WAS CAUSING MORE PAIN. THE INS WAS PUSHING AGAINST THE PATIENT¿S SKIN. IT WAS NOTED THAT THIS HAD BEEN GOING ON FOR A FEW MONTHS. THE PATIENT MAY ALSO NEED TO HAVE THE DEVICE EXPLANTED TO HAVE MRI¿S TO CHECK HIS NERVE PAIN IN HIS BACK. IT WAS NOTED THAT THE THERAPY WAS NOT WORKING AS EXPECTED. THE COMPANY REPRESENTATIVE CONFIRMED THAT THE BATTERY WAS CURRENTLY OVER-DISCHARGED. THE HEALTH CARE PROFESSIONAL TOLD THE PATIENT TO LEAVE THE DEVICE IN. THE PATIENT WISHED HE COULD USE THE DEVICE WITHOUT HAVING TO RECHARGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SEEMED TO DO WELL WITH THE DEVICE INITIALLY BUT THEN THERE WAS A PERIOD OF TIME WHEN HE WAS NOT ABLE TO RECHARGE HIS GENERATOR. AS A RESULT THE BATTERY WENT DEAD AND COULD NOT BE RESTARTED OR RECHARGED. THE PATIENT STATED THAT HE DID NOT REALLY GET THAT MUCH HELP FROM THE DEVICE ANYWAY AND WAS NEVER REALLY SATISFIED WITH THE RESULTS FROM THE SPINAL CORD STIMULATION (SCS). IT WAS NOTED THAT THE PATIENT WANTED IT REMOVED. THE PATIENT NEEDED SOME MRI SCANS OF THE HEAD TO EVALUATE SOME COGNITIVE PROBLEMS HE WAS EXPERIENCING AND THERE MAY BE AN ISSUE WITH HAVING THEM DONE WITH THE SCS IN PLACE. IT WAS NOTED THAT THE PATIENT HAD PAIN IN THE LOWER BACK THAT WAS RADIATED TO THE RIGHT ANKLE, RIGHT CALF, RIGHT FOOT AND RIGHT THIGH. IT WAS NOTED THAT SYMPTOMS WERE AGGRAVATED BY DAILY ACTIVITIES AND WERE RELIEVED BY PAIN MEDICATIONS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD THE PAINFUL AND NON-FUNCTIONAL SPINAL CORD STIMULATOR REMOVED ON (B)(6) 2014. IT WAS NOTED THAT DURING EXPLANT THE LEAD WIRES WERE CUT AND BOTH ENDS WERE REMOVED WITHOUT COMPLICATION. THE PATIENT POST-OPERATIVELY WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727536 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 00058 YR Required Intervention