BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3951076 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13380
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 30, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37714, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37714, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 97754, SERIAL # (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID 97740 LOT# SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED A LOSS OF STIMULATION/THERAPEUTIC EFFECT AND MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT WAS SEEN BY THE NEUROSURGEON ON 2014 (B)(6). IMAGES (X-RAYS) OF THE SPINE AND DEVICE POCKET LOCATION WERE TAKEN. THE PHYSICIAN REPORTEDLY DETERMINED ONE OR BOTH OF THE LEADS WERE DISCONNECTED FROM THE STIMULATION IMPLANTABLE NEUROSTIMULATOR (INS). THE ISSUE WAS NOT RESOLVED. THE CAUSE OF THE ISSUE WAS REPORTEDLY UNKNOWN. IT WAS NOTED A MANUFACTURER REPRESENTATIVE (REP) WOULD BE MEETING WITH THE PATIENT ON 2014 (B)(6) TO CHECK THE SPINAL CORD STIMULATION SYSTEM, INCLUDING ELECTRICAL IMPEDANCES AND DEVICE BATTERY CHARGE LEVELS. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. NO COMPLICATIONS WERE REPORTEDLY ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ONE LEAD WAS DISCONNECTED FROM THE INS. IT WAS REPORTED THAT NO TROUBLESHOOTING OR OTHER ACTIONS HAD BEEN TAKEN TO RESOLVE THE EVENT. IT WAS NOTED THAT LEAD REVISION SURGERY WAS BEING PLANNED BUT THAT A DATE HAD NOT BEEN DETERMINED YET. THE PATIENT WAS REPORTEDLY RECEIVING EFFECTIVE THERAPY WITH THE OTHER LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR EXPLORATORY SURGERY ON THE DAY OF REPORT. THE PATIENT LOST STIMULATION COVERAGE ON THE RIGHT LEAD WITH EXTENSION TO THE IMPLANT. THE LEFT LEAD WAS WORKING FINE. THE REPORTER DID NOT KNOW WHEN THE EVENT STARTED BUT IT HAD BEEN A FEW MONTHS. ELECTRODES 11-15 SHOWED OUT OF RANGE IMPEDANCE. AN X-RAY SHOWED THAT THE RIGHT LEAD/EXTENSION HAD BEEN PULLED OUT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SOCKET. THE ELECTRICAL IMPEDANCES WERE TAKEN PRIOR TO SURGERY. ON THE SECOND LEAD (ELECTRODES 8-15) THERE WERE OUT OF RANGE HIGH IMPEDANCES ON ELECTRODES 11-15. INTRA OPERATIVE IMAGES SHOWED EVIDENCE OF THE LEAD CONTACTS RETRACTED FROM LOWER SOCKET OF THE INS. THE INS POCKET WAS OPENED AT SURGER AND THE LEAD RETRACTION WAS CONFIRMED. THE HEALTHCARE PROFESSIONAL (HCP) REMOVED THE LEAD FROM THE SOCKET AND DRIED THE CONTACTS AND INTRA OPERATIVE IMPEDANCES WERE TAKEN AND SHOWED NORMAL ON 11, 12, 13, AND 15. OUT OF RANGE IMPEDANCES WERE SEEN ON ELECTRODES 10 AND 14. THE HCP REPEATED THIS 3-5 MORE TIMES AND OUT OF RANGE IMPEDANCES REMAINED ON ELECTRODES 10 AND 14. NO OTHER CONCERNS WERE RAISED DURING SURGERY. THE PATIENT WAS REPROGRAMMED AFTER SURGERY USING THE ACTIVE NORMAL RANGE IMPEDANCE ELECTRODES AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427932 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention