BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4171076 · Received October 14, 2014

    Report

    Report Number
    3004209178-2014-19677
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377760, LOT# V001491, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR MANUFACTURING REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON 2014 (B)(6). THE BATTERY LIFE OF THE UNIT HAD RUN OUT AND THE UNIT NEEDED TO BE MOVED TO A NEW SPOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANT WAS RIGHT ON THE BELT LINE SO IT WAS HURTING AND RAW AND CAUSED ISSUES WITH CLOTHING. IT WAS NOTED IT HAD BEEN THIS WAY SINCE THE TIME OF IMPLANT, BUT IN THE BEGINNING HE THOUGHT IT WAS JUST BECAUSE IT NEEDED TIME TO HEAL. THE PATIENT REPORTED THAT THEY WOULD BE MOVING THE DEVICE TO A DIFFERENT SPOT ON HIS BODY. IT WAS ALSO REPORTED THAT THE PATIENT HAD ISSUES WITH COVERAGE WHICH BEGAN IN 2008 OR 2009. STIMULATION WAS GETTING TO SOME OF THE POINTS BUT NOT IN THE SCIATICA OR DOWN INTO THE TAILBONE AREA. HE THOUGHT IN THE BEGINNING IT WOULD JUST TAKE TIME FOR THE BODY TO RECOGNIZE THE STIMULATION. TO COUNTER THE EFFECT THEY DID INJECTIONS IN THE BACK AND LOWER AREA, AND FINALLY IN THE SCIATICA AND JOINTS BUT THIS DID NOT HELP AND THE ISSUE PERSISTED. A CAT SCAN WAS PERFORMED TO FIND OUT WHERE TO PUT THE LEADS TO HOPEFULLY REACH THE AREAS HE NEEDED. THE PATIENT WAS HAPPY WITH HIS DEVICE AND HAD FAITH THEY WOULD BE ABLE TO GET IT IN THE CORRECT LOCATION. IT WAS NOTED THE PATIENT NEVER TURNED HIS OFF. THE PATIENT ALSO REPORTED THE DISPLAY ON THE PATIENT PROGRAMMER SHOWED THE ¿CALL YOUR DOCTOR¿ ICON. HE REPORTED SEEING THE DOCTOR FACE BUT COULDN¿T REMEMBER WHAT THE CODE WAS UNDER THE DOCTOR FACE. THE ISSUE BEGAN ABOUT ONE WEEK PRIOR TO THE REPORT. THE PATIENT WAS ABLE TO CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) CODE WAS SEEN. IT WAS REVIEWED WITH THE PATIENT THAT THIS INDICATED THE BATTERY WAS NEARING END OF SERVICE AND WOULD NEED REPLACING. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE MANUFACTURING REPORT 3004209178-2014-19672.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651293 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention