BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4369742 · Received December 30, 2014

    Report

    Report Number
    3004209178-2014-24649
    Event Type
    Injury
    Date Received
    December 30, 2014
    Report Date
    December 9, 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

    UPDATES TO CONCLUSION CODING WERE MADE. IS RELATED TO THE INS, S/N (B)(4), AND IS RELATED TO THE LEAD, LOT # V218547032. ANALYSIS OF THE INS, S/N (B)(4), FOUND THE BATTERY HAD REDUCED CAPACITY DUE TO OVER-DISCHARGE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT # V218547032, FOUND THE CONDUCTOR WAS BROKEN AT THE ANCHOR SITE. ALL WIRES WERE BROKEN 20.5CM FROM THE DISTAL END. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. UPON FURTHER REVIEW IT WAS DETERMINED THAT CONCLUSION CODE 92 NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3550-39, LOT# N246304, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD WAS EXPLANTED ON (B)(6) 2015 BECAUSE THE THERAPY/STIMULATION HAD ¿QUIT WORKING.¿ DURING AN APPOINTMENT IN WHICH THE DEVICE WAS ¿JUMP-STARTED¿ IT WAS DETERMINED THAT THE RIGHT LEAD WAS ¿BAD¿. DURING THE LEAD EXPLANT THE LEADS AND EXTENSIONS WERE CUT BY THE HEALTH CARE PROVIDER (HCP). POST-OP THE PATIENT WAS NOTED TO BE DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD HIGH IMPEDANCES ON THEIR RIGHT LEAD WHICH WAS ELECTRODES 8 THROUGH 15. WITH ELECTRODE 2 USED AS THE REFERENCE ELECTRODE THE IMPEDANCE MEASUREMENTS WERE: ELECTRODE 0: 1048 OHMS ELECTRODE 1: 1171 OHMS ELECTRODE 3: 992 OHMS ELECTRODE 4: 1054 OHMS ELECTRODE 5: 1220 OHMS ELECTRODE 6: 1066 OHMS ELECTRODE 7: 941 OHMS ELECTRODE 8: 11769 OHMS ELECTRODE 9: 13037 OHMS ELECTRODE 10: >20000 OHMS ELECTRODE 11: >20000 OHMS ELECTRODE 12: >20000 OHMS ELECTRODE 13: >20000 OHMS ELECTRODE 14: >20000 OHMS ELECTRODE 15: >20000 OHMS TROUBLESHOOTING WAS DONE ON THE DAY OF THE REPORT BUT THE IMPEDANCES REMAINED HIGH. THE PATIENT WAS REPROGRAMMED. THE PATIENT WAS RECEIVING GOOD THERAPY ON THEIR LEFT SIDE, LEG AND BACK. THEY WERE GETTING NO STIMULATION ON THE RIGHT SIDE DUE TO THE HIGH IMPEDANCES ON THE RIGHT LEAD. THE PATIENT WAS UNDECIDED IF THEY WANTED TO DO A REVISION OF THE RIGHT LEAD. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR LUMBAR RADICULOPATHY. IT WAS REPORTED THE PATIENT'S DEVICE WORKED FOR A FEW YEARS AND THEN THEY QUIT USING IT. IN (B)(6) 2015 THE DEVICE WAS "JUMP-STARTED" BY A MANUFACTURER REPRESENTATIVE. DURING A LEAD EXPLANT, THE DEVICE WAS UNABLE TO BE CHECKED BECAUSE IT WAS DISCHARGED. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REPORTED PREVIOUSLY REPORTED INFORMATION WAS UNTRUE AS THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS), AS WELL AS HER LEADS, SURGICALLY REMOVED ON (B)(6) 2015. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860117 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