BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3671084 · Received March 10, 2014

    Report

    Report Number
    3004209178-2014-04190
    Event Type
    Injury
    Date Received
    March 10, 2014
    Report Date
    February 18, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REVISION, THE PATIENTS LEADS WERE PARTIALLY REMOVED AND A NEW LEAD WAS PLACED. INTRA OPERATIVE TESTING SHOWED IMPEDANCES OUT OF RANGE. THE PATIENT WAS DOING WELL AFTER THE REVISION AND WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF STIMULATION HAD OCCURRED THOUGH WHEN THE LOSS OF STIMULATION OCCURRED COULD NOT BE CONFIRMED AT THE TIME OF REPORT. IT WAS LOGGED THAT THE PATIENT COULD NOT RECALL ANY FALLS. IT WAS NOTED THE PATIENT WAS HAVING AN X-RAY DONE DURING THE TIME OF THE CALL. IT WAS REPORTED THE PATIENT'S COVERAGE WAS MOSTLY CENTERED AROUND THE 0-7 LEAD. IT WAS LOGGED THAT IMPEDANCES WERE TESTED AT 3V WITH REFERENCE 0 AND ALL CONTACTS WERE >40,000 OHMS, THEN WITH REFERENCE 4 ONLY 0 WAS AT >40,000 OHMS AND EVERYTHING ELSE WAS BETWEEN "243888-30000" OHMS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR LEADS PARTIAL EXPLANTED. IT WAS NOTED THAT ONCE IT WAS DETERMINED THAT THE LEAD WAS NOT WORKING THE DOCTOR ATTEMPTED TO REMOVE IT, HOWEVER, HE WAS ONLY ABLE TO PULL OUT HALF. THE LEAD SOMEHOW (NOT BY THE DOCTOR DURING THE CASE) HAD BEEN CUT OR BROKEN IN HALF AND SO THE PART IN THE SPINE REMAINS. THERE WAS REPORTEDLY AN IMPEDANCE ISSUE WITH IMPEDANCES GREATER THAN 10,000. IT WAS ALSO NOTED THAT THE LEAD WAS BROKEN IN THE MIDDLE AND THERE WAS A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. ACTIONS REQUIRED AS A RESULT OF THIS EVENT WERE REPLACEMENT. IT WAS FURTHER NOTED THAT X-RAYS AND IMPEDANCE TESTING WERE DONE AND THE ISSUE RESOLVED. IT WAS THEN REPORTED THAT ONE LEAD TESTED HIGH AND WAS DETERMINED TO HAVE AN ISSUE, IT WAS NOTED THE BATTERY WAS NOT THE ISSUE. WHEN THE DOCTOR ATTEMPTED TO REMOVE THE LEAD HE DISCOVERED THAT IT WAS COMPLETELY BROKEN IN HALF NEAR THE AREA WHERE IT EXITED THE SPINE. FURTHER INTO THE PROCEDURE, WHILE REPLACING THE ORIGINAL LEAD, HE DISCOVERED THE SECOND LEAD WAS BROKEN IN HALF AS WELL. IT WAS NOTED THAT THE PATIENT'S STIMULATION HAD STOPPED WORKING AND THAT THEY WERE ALIVE WITH NO INJURY. IT WAS REPORTED THAT DURING THE REVISION, THE PATIENTS LEAD WERE PARTIALLY REMOVED AND A NEW LEAD WAS PLACED. INTRA OPERATIVE TESTING SHOWED IMPEDANCES OUT OF RANGE. THE PATIENT WAS DOING WELL AFTER THE REVISION AND WAS RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE LEADS THEY WERE BOTH SHEARED/CUT/WORN IN HALF AND THEREFORE HE WAS ONLY ABLE TO GET HALF OR EACH LEAD OUT OF THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT PART OF THE LEAD THAT WAS IN THE EPIDURAL SPACE WAS LEFT IN THE PATIENT BECAUSE THE PHYSICIAN COULD NOT GET IT OUT. IT WAS NOTED THAT ONLY THE PREVIOUSLY IMPLANTED LEADS HAD IMPEDANCE ISSUES AND THE NEW LEAD WAS WORKING JUST FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF STIMULATION HAD OCCURRED THOUGH WHEN THE LOSS OF STIMULATION OCCURRED COULD NOT BE CONFIRMED AT THE TIME OF REPORT. IT WAS LOGGED THAT THE PATIENT COULD NOT RECALL ANY FALLS. IT WAS NOTED THE PATIENT WAS HAVING AN X-RAY DONE DURING THE TIME OF THE CALL. IT WAS REPORTED THE PATIENT'S COVERAGE WAS MOSTLY CENTERED AROUND THE 0-7 LEAD. IT WAS LOGGED THAT IMPEDANCES WERE TESTED AT 3V WITH REFERENCE 0 AND ALL CONTACTS WERE >40,000 OHMS, THEN WITH REFERENCE 4 ONLY 0 WAS AT >40,000 OHMS AND EVERYTHING ELSE WAS BETWEEN "243888-30000" OHMS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143365 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