BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3940795 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13143
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # V766316, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # V766316, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR ((B)(4)) FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD ((B)(4)) FOUND #0 AND 4 WIRES BROKEN NEAR THE ELECTRODE WELD.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THE PATIENT HAD GREATER THAN FIFTY PERCENT SYMPTOM RELIEF. IT WAS NOTED THE CAUSE OF THE EVENT WAS NOT DETERMINED AND REPROGRAMMING WAS NOT NEEDED. IT WAS REPORTED THE PATIENT HAD A CT SCAN ON (B)(6) 2014 ALONG WITH DEVICE INTERROGATION. IT WAS NOTED THE PATIENT¿S SYMPTOMS WERE ONGOING. IT WAS REPORTED THE SYSTEM WAS REPLACED. IT WAS REPORTED THE OLD SYSTEM HAD HIGH IMPEDANCES ON TWO CONTACTS THAT COULD NOT BE PROGRAMMED AROUND. IT WAS NOTED THE LEAD HAD MIGRATED INFERIORLY. IT WAS REPORTED SCAR TISSUE WAS REMOVED FROM THE EPIDURAL SPACE DURING REPLACEMENT. IT WAS NOTED THAT FLUOROSCOPY VERIFIED GOOD LEAD AND STIMULATOR PLACEMENT. IT WAS REPORTED THE PATIENT HAD RIGHT ARM NEUROPATHIC PAIN PRIOR TO REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT THE FOLLOW UP VISIT FOLLOWING THE GENERATOR AND LEAD REPLACEMENT, COVERAGE WAS APPROPRIATE AND IMPEDANCES WERE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DOING WELL AND HAD APPROPRIATE COVERAGE. IT WAS REPORTED NORMAL THERAPY HAD RESUMED.

    Description of Event or Problem · 1

    THE STIMULATION WAS TURNING OFF AND ON. FOR ABOUT A MONTH THE STIMULATION WOULD RANDOMLY TURN OFF AND THEN TURN ITSELF BACK ON. THE BODY POSITION DID NOT MATTER (STAND/SIT) NOR DID THE TIME OF DAY. IT HAPPENED AT RANDOM TIMES A DAY. THERE WERE NO FALLS OR TRAUMAS. THERE WAS ALSO NO RECENT PROGRAM CHANGES. THE OCCURRENCE WAS RANDOM. THE PATIENT WAS CHARGING MORE THAN EXPECTED. CURRENTLY THE PATIENT WAS RECHARGING EVERY 3-4 WEEKS AND HAS ¿DEALT WITH THAT¿. THE CHANGE FROM CHARGING EVERY 3 MONTHS TO EVERY MONTH WAS A RESULT FROM THE NEW LEAD IMPLANTED. THE PATIENT WOULD LIKE THE IMPEDANCES CHECKED ON HIS DEVICE. THE PATIENT WAS TOLD TO ASK HIS HCP IF AN X-RAY OF THE SPINE COULD BE DONE. IT WAS ADDITIONALLY REPORTED THAT THE INS HAD BEEN ¿MISFIRING¿ AND PROVIDED INTERMITTENT STIMULATION. A WEEK LATER IMPEDANCE MEASUREMENTS OF GREATER THAN 10,000 OHMS WAS REPORTED. ELECTRODES 0 AND 4 WERE HIGH ACROSS THE BOARD. X-RAYS REVEALED THE BOTTOM 2 ELECTRODES ON THE PADDLE WERE PROBABLY OFF THE DURA AND PULLING OUT OF THE EPIDURAL SPACE. THE DEVICE WAS PROGRAMMED WITH MIDDLE 4 ELECTRODES AROUND IMPEDANCE ISSUES AND THE PATIENT LEFT WITH SATISFACTORY COVERAGE OF HIS PAINFUL AREAS. THE TELEMETRY REPORT WAS SAVED. THE PATIENT NOTICED INCONSISTENT BATTERY CHARGING INTERVALS. THE PLAN MOVING FORWARD WAS TO UTILIZE WHAT APPEARED TO BE 4 FUNCTIONAL ELECTRODES AND HOPE THE PADDLE LEAD DOES NOT NEED TO BE REPLACED. THE PATIENT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ELECTRODES HAD NOT MIGRATED PER X-RAY BUT THERE MAY BE WAS A BREAK IN THE PATIENT¿S SYSTEM. IT WAS NOTED THAT IT WAS THOUGHT THERE WAS A DISCONNECT. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF A LEAD FRACTURE. THE REPORTER NOTED THAT IMPEDANCES WERE CHECKED. THE REPORTER NOTED THAT THE RECHARGE INTERVAL WAS GETTING SHORTER AND SHORTER. IT WAS NOTED THAT THE PATIENT HAD NOT RECOVERED AND THAT THE SYMPTOMS/ISSUE WAS ONGOING. THE REPORTER NOTED THAT THE PATIENT WAS GOING TO HAVE AN EXPLORATION/POSSIBLE REVISION SURGERY. IT WAS NOTED THAT IT APPEARED THE ¿DEVICE WAS NOT WORKING.¿ IT WAS FURTHER NOTED THAT THERE WERE SOME CONCERNS REGARDING EFFICIENCY OF THE PATIENT¿S SYSTEM AND THE NEED TO CHARGE MORE FREQUENTLY THAN IN THE PAST. THE REPORTER NOTED THAT WHEN THE SYSTEM WAS INTERROGATED, IT WAS FOUND THAT THE INFERIOR TWO CONTACTS HAD HIGH IMPEDANCE AND THAT IT CORRELATED WITH THE ELECTRODES NOT BEING REALLY WELL APPROXIMATED AGAINST THE SPINAL CORD INFERIORLY. THE REPORTER NOTED THAT THERE HAD BEEN NO MOVEMENT OF THE PATIENT¿S CERVICAL SPINAL ELECTRODES AND THAT THE BOTTOM TWO CONTACTS WERE JUST NOT TIGHTLY OPPOSED TO THE DURA. IT WAS NOTED THAT THIS HAD NOT CHANGED IN OVER A YEAR FROM WHAT WOULD BE SEEN ON THE X-RAYS. WHEN REPROGRAMMING THE PATIENT, ELIMINATING THE BOTTOM CONTACTS RESULTED IN A MUCH MORE EFFICIENT USE OF THE ENERGY AND TURNED OUT WITH A MUCH BETTER COVERAGE. THIS WOULD IN TURN ALLOW THE PATIENT¿S UNIT TO CHARGE MORE EFFICIENTLY AND RESULT IN LESS POWER DRAINAGE. THE PATIENT LEFT THE CLINIC WITH GOOD RESULTS FROM STIMULATION THERAPY AND THE HEALTH CARE PROFESSIONAL DID NOT FEEL THAT THERE WAS ANY EVIDENCE OF A PROBLEM WITH THE SYSTEM. THEY WERE ABLE TO IMPROVE THE PROGRAMMING OF THE DEVICE TO A BETTER STATE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE THE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REPLACED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE PATIENT STARTED TO EXPERIENCE SHOULDER PAIN 2-3 MONTHS AFTER THE LEAD REVISION (SEE MANUFACTURER REPORT # 3004209178-2014-13118). THE PATIENT¿S HEALTH CARE PROVIDER NOTIFIED THE PATIENT IN JANUARY 2014 THAT THEY THOUGHT THE LEADS SLIPPED. THE PATIENT THOUGHT THE LEADS ACTUALLY STARTED SLIPPING IN 2012 AFTER THE LEAD REVISION (SEE MANUFACTURER REPORT # 3004209178-2014-13118). TO TRY TO HELP BATTERY LIFE AND POTENTIAL LEAD SLIPPING THEY TURNED OFF BOTTOM 2 ¿LEADS¿ IN (B)(6) 2014 BECAUSE THEY WERE SHOOTING NOWHERE. TURNING THOSE LEADS OFF MADE THE SHOULDER PAIN BETTER AND GAVE THE PATIENT MORE MOVEMENT. THE SHOULDER PAIN WAS NOT GONE AND WAS NOT RELATED TO THE REASON THE PATIENT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT SINCE REVISION, THE PATIENT HAD INTERMITTENT PAIN ACROSS THE LEFT NECK AND SHOULDER. THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 3004209178-2014-13127 AND UPON FURTHER REVIEW NOW PERTAINS TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A COMPLETE EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS), LEAD AND EXTENSION ON (B)(6) 2014. IT WAS NOTED THAT THE LEAD HAD MIGRATED AND WAS IDENTIFIED AS THE CAUSE OF INAPPROPRIATE STIMULATION COVERAGE. IT WAS NOTED THAT THERE WAS STIMULATION IN THE WRONG LOCATION. THE REPORTER NOTED THAT IMPEDANCES WERE OUT OF RANGE AT THE REPROGRAMMING SESSION AND THAT X-RAYS WERE ALSO PERFORMED. IT WAS NOTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE ON THE EXTENSION. PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED SPASM AT THE LEAD LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418658 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention