BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4024793 · Received August 20, 2014

    Report

    Report Number
    3004209178-2014-15621
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE ¿ER¿ (EMERGENCY ROOM) THE MORNING OF (B)(6) 2014 WITH SEVERE SPASTICITY AND A LITTLE ITCHING. THE REPORTER STATED THAT THE SPASTICITY WAS LIKE THE PATIENT WAS ¿AT THE BEGINNING, BEFORE THE PUMP WAS IMPLANTED.¿ THE REPORTER STATED THAT THERE WERE NO ALARMS, AS WELL AS NO DISCREPANCY ON THE LAST REFILL ON (B)(6) 2014. THE REPORTER READ BACLOFEN FROM THE PROGRAMMER, BUT STATED THAT THEY BELIEVED THE MEDICATION TO BE LIORESAL. THE REPORTER PLANNED TO GET SOME IMAGING OF THE SYSTEM/X-RAY OF THE CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS MIGRATION/DISLODGEMENT OF THE CATHETER TIP. THE PATIENT EXPERIENCED INCREASED SPASTICITY, AND UNDERDOSE SYMPTOMS WHICH WERE FURTHER SPECIFIED AS RETURN OF SPASTICITY, ¿N/V¿ (NAUSEA AND VOMITING), AND HEADACHE. THE PATIENT WAS HOSPITALIZED; SURGICAL INTERVENTION WAS PERFORMED AND THE CATHETER WAS REPLACED. AS OF (B)(6) 2014, THE PATIENT WAS ALIVE WITH NO INJURY. THE PUMP WAS BEING USED TO DELIVER LIORESAL. IT WAS FURTHER REPORTED THAT DURING THE SURGERY ON (B)(6) 2014 (AS PREVIOUSLY REPORTED); A NEW SPINAL SEGMENT WAS PLACED, AS THE ORIGINAL SPINAL SEGMENT HAD DISLODGED. THE PATIENT WAS RESTARTED ON BACLOFEN AND KEPT AS AN INPATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED, FOLLOWING THE PUMP IMPLANT, THE PATIENT SEEMED TO BE DOING WELL. ON (B)(6) 2014, THE PATIENT SPOKE WITH HER HCP AND COMPLAINED OF SEVERE INCREASED LOWER EXTREMITY SPASMS, BUT NO ITCHING, SWEATING, OR OTHER SIGNS OF BACLOFEN WITHDRAWAL. BECAUSE THE PATIENT WAS NOT HAVING OTHER WITHDRAWAL SYMPTOMS, SHE WAS TOLD TO SEE THE HCP THE FOLLOWING MORNING. HOWEVER, THAT MORNING, THE HCP RECEIVED A CALL THAT THE PATIENT HAD BEEN IN THE EMERGENCY ROOM (ER) SINCE THE SAME MORNING. WORKUP WAS NEGATIVE AND THE PATIENT WAS BEING DISCHARGED. WHILE THE PATIENT WAS WAITING TO BE DISCHARGED, SHE BEGAN HAVING INCREASING LEVELS OF SPASMS. THE PATIENT¿S HCP WENT TO SEE HER IN THE ER. THE PATIENT¿S PUMP WAS INTERROGATED AND NO ALARMS WERE NOTED. AT THIS TIME, THE PATIENT WAS ON THE SAME STANDARD DOSE THAT SHE HAD BEEN PREVIOUSLY, WHICH WAS APPROXIMATELY 960MCG/DAY IN FLEX DOSING. AT THIS TIME, THE PATIENT HAD BEEN EXPERIENCING PAIN, STIFFNESS/SPASTICITY AND DIFFICULTY WALKING. THE PATIENT¿S SYMPTOMS HAD BEEN MORE FOR THE PREVIOUS 4 DAYS. UPON PHYSICIAN EXAMINATION, THE PATIENT HAD MARKED BILATERAL LOWER EXTREMITY SPASMS WITH MODIFIED ASHWORTH SCORES OF 4 IN THE HIP EXTENSORS, KNEE EXTENSORS AND ANKLE PLANTAR FLEXORS. THE PATIENT ALSO HAD MARKED LOWER EXTREMITY SPASTICITY WITH RIGID QUADRICEPS AND HIP EXTENSORS WITH A MODIFIED ASHWORTH OF 4. THIS WAS REMINISCENT OF HOW SHE LOOKED PRIOR TO HER PUMP PLACEMENT. STAT X-RAYS WERE DONE AND THE PUMP AND CATHETER APPEARED TO BE IN NORMAL LOCATION. THE CATHETER ACCESS PORT (CAP) WAS AT THE 9 O-CLOCK POSITION. THE CATHETER WAS DOUBLE BACK ON ITSELF. IT APPEARED TO BE ON THE ¿AP¿, HOWEVER, ON THE LATERAL THE SUBCUTANEOUS PORTION TRAVELED FROM L2 DOWN TO APPROXIMATELY L5 BEFORE ENTERING THE SPINOUS LIGAMENT AREA AND THE CANAL. THE SPINAL FUSION HARDWARE L4, L5, AND S1 PEDICLE SCREWS WERE INTERFERING WITH THE IMAGE AND THE CATHETER COULD NOT BE VISUALIZED. ON THE ANTERIOR-POSTERIOR VIEW, THE DISTAL END OF THE BACK OF THE CATHETER PROJECTED OVER THE REGION OFF THE L4-L5 VERTEBRAL BODIES IN THE LATERAL VIEW OF THE DISTAL END OF THE CATHETER APPEARED TO BE WITHIN THE POSTERIOR SOFT TISSUES OFF THE LOWER BACK. THE VERY TIP OF THE CATHETER WAS OBSCURED IN THE LATERAL VIEW BY POST-SURGICAL CHANGES IN THE LOWER LUMBAR SPINE. IT WAS NOTED THAT, IF INDICATED, A LIMITED CT SCAN OF THE LOWER ABDOMEN AND UPPER PELVIS COULD BE PERFORMED FOR CONFIRMATION. IT DID SEEM THAT THE TIP MAY OR MAY NOT HAVE BEEN IN THE SPINAL CANAL, AND MAY HAVE BEEN IN THE SOFT TISSUES OF THE POSTERIOR LOWER BACK, BUT IT WAS VERY DIFFICULT TO MAKE OUT. AFTER REVIEWING X-RAYS, THE HCP SAW NO EVIDENCE OF CATHETER FRACTURE DISPLACEMENT. THEREFORE, A BLIND CAP ASPIRATION WAS ATTEMPTED AT THE BEDSIDE. APPROXIMATELY 45 MINUTES WAS GIVEN TO TRYING TO ACCESS BASED ON THE PATIENT¿S ANATOMY AND LOCATION OF THE PUMP ON THE ANTERIOR-POSTERIOR AND LATERAL X-RAYS. UNFORTUNATELY, THE PATIENT¿S OBESITY MADE THE PUMP VERY DIFFICULT TO FEEL AND, THEREFORE, THE ASPIRATION WAS NOT SATISFACTORY, AT ONE POINT, IT FELT LIKE THE NEEDLE WAS IN THE CAP AND THE ASPIRATION WAS ¿DRIED¿, BUT IT WAS NOT RELIABLE ENOUGH TO COMMIT THE PATIENT TO SURGERY. AT THIS TIME, IT WAS NOTED THAT THERE WAS A HIGH LIKELIHOOD OF A CATHETER MALFUNCTION. CLINICALLY, THE PATIENT HAD MARKED REBOUND SPASTICITY WITH ONLY SLIGHT ITCHING, WHICH WAS ADMITTED AS A SIGN OF BACLOFEN WITHDRAWAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE HCP RECOMMENDED THAT THE PATIENT BE STARTED ON HIGH-DOSE ORAL BACLOFEN 20MG, FOUR TIMES PER DAY. THERE WAS NO NEED FOR PERIACTIN AT THIS TIME, AS THE PATIENT WAS NOT HAVING OTHER SYSTEMIC WITHDRAWAL SYMPTOMS. ON THE SAME DATE, A FLUOROSCOPIC-GUIDED CAP ASPIRATION PROCEDURE WAS DONE. THE PUMP WAS VISUALIZED AND WAS IN THE CORRECT ANATOMICAL POSITION. UTILIZING EXTERNAL GUIDANCE WITH A SPINAL NEEDLE, THE SITE WHERE THE CAP WAS LOCATED WAS IDENTIFIED. AFTER SEVERAL ATTEMPTS, THE PORT WAS ACCESSED AND VERIFIED ON ZOOM IMAGE OF THE PUMP. THE RUBBER STOPPER FEEL WAS NOTED AT THE INSERTION OF THE NEEDLE. AGGRESSIVE ASPIRATION WITH THE SYRINGE RESULTED IN NO FLUID FLOWING. FOLLOWING THIS PROCEDURE, IT WAS DETERMINED THAT A CATHETER OCCLUSION HAD OCCURRED. THE SITE OF THE OCCLUSION WAS UNKNOWN AT THIS TIME AND IT COULD HAVE BEEN ANYWHERE FROM THE PROXIMAL TO THE DISTAL TIP. HOWEVER, IT WAS NOTED THAT THE MOST COMMON SITES WERE AT THE CONNECTOR, IN THE TRANSITION ZONE IN THE LUMBAR SPACE WHERE IT ENTERED THE SPINAL CANAL OR, LASTLY, AT THE CATHETER TIP. THE PUMP WAS TURNED DOWN IN PREPARATION FOR THE SURGERY TO AVOID OVERDOSE. HIGH DOSE ORAL BACLOFEN WAS PRESCRIBED TO TREAT BACLOFEN WITHDRAWAL AND PERIACTIN TO TREAT WITHDRAWAL SYMPTOMS. BLOOD WORK WAS TO BE MONITORED TO INDICATE THE POSSIBILITY OF RHABDOMYOLYSIS. THE FOLLOWING DAY, A CATHETER REPLACEMENT WITH LAMINECTOMY WAS DONE. UPON OPENING THE BACK INCISION, THE CATHETER WAS ABLE TO BE FOUND. WHEN THE HCP DISSECTED OUT THE CONNECTION BETWEEN THE INTRATHECAL AND ABDOMINAL PORTIONS, HE WAS ABLE DISCONNECT IT AND NO CEREBROSPINAL FLUID (CSF) FLOW WAS SEEN. ASPIRATION WAS ALSO ATTEMPTED AND WAS UNSUCCESSFUL, SO THE CATHETER WAS REMOVED. IT WAS NOTED THAT ¿WITH BRISK FLOW OF CSF FROM THE TRACH, WHICH WAS SUTURED CLOSED¿. HOWEVER, IT WAS UNCLEAR WHAT THIS MEANT. NUMEROUS ATTEMPTS OF LUMBAR PUNCTURE WERE DONE AND, BECAUSE OF PREVIOUS FUSION IMPLANTS, THE HCP WAS UNABLE TO PLACE THE CATHETER. IT WAS EVEN DONE UNDER FLUOROSCOPIC CONTROL AND THE SPINAL PROCESS WAS CUT DOWN TO WHAT WAS LIKELY L3. ONCE THE SPINOUS PROCESS WAS IDENTIFIED, THE HCP ATTEMPTED TO PLACE THE CATHETER SEVERAL TIMES, BUT WAS UNABLE TO. THE HCP PLACED THE NEEDLES AND COMPLETED THE LUMBAR PUNCTURE. A LAMINECTOMY WAS COMPLETED, REMOVING THE SPINOUS PROCESS AND COMING STRAIGHT DOWN INTO THE CANAL USING CURETTES, KERRISON PUNCHES, REMOVED THE LIGAMENTUM FLAVUM. THE HCP WAS ABLE TO IDENTIFY THE THECAL SAC. NEXT, WITH DIRECT VISUALIZATION, A LUMBAR PUNCTURE WAS COMPLETED AND HE GOT CSF AND WAS ABLE TO PASS THE CATHETER. UNFORTUNATELY, THE CATHETER WAS ONLY UP, BUT THE HCP GOT PAST APPROXIMATELY 3 SEGMENTS AND THEN IT SEEMED TO START LOOPING ON ITSELF, SO THE HCP LEFT THE CATHETER AT ABOUT T11-T12. THE HCP DID PLACE FIBRIN GLUE AROUND THE DURA AT THE ENTRANCE SITE TO HOPEFULLY SEAL OFF ANY CSF. THE PARASPINAL MUSCLES WERE THEN CLOSED. PRIOR TO CONNECTING THE CATHETER AND CLOSING THE SPINAL INCISION, THE HCP DID HAVE TO MAKE A SPINAL INCISION OVER THE PUMP AND PLACED A NEEDLE INTO THE AREA, CONFIRMING THAT THE CATHETER FROM THE PUMP TO THE BACK FLOWED NICELY, AS HE WAS ABLE TO INJECT AND GOT FLOW FROM THE CATHETER PRIOR TO CONNECTING IT TO THE PERITONEAL AND INTRATHECAL. THE ABDOMINAL INCISION WAS CLOSED. FOLLOWING THE CATHETER REPLACEMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL. UPON ADMISSION, THE PATIENT EXPERIENCED DIZZINESS, A HEADACHE, NAUSEA, VOMITING, AND AN INABILITY TO MOVE BECAUSE OF HER PUMP NOT WORKING. THE PATIENT WAS GOING INTO BACLOFEN WITHDRAWAL. THE PATIENT ALSO STARTED TO EXPERIENCED FEVERS AND POSSIBLE PNEUMONITIS AND BRONCHITIS. SHE WAS STARTED ON ANTIBIOTICS. WHILE THE PATIENT WAS ON THE PUMP, SHE WAS GETTING DOSE INCREASES AND ORAL DOSES WERE DECREASED. THE PATIENT WENT INTO ACUTE RENAL FAILURE, WHICH LED TO CUMULATION OF LYRICA AND OTHER PSYCHOTROPIC MEDICATIONS. THE PATIENT STARTED TO EXPERIENCE AN ALTERED MENTAL STATUS. SHE WAS PLACED ON INTRAVENOUS (IV) HYDRATION AND MEDICATIONS WERE HELD FOR RENAL INSUFFICIENCY, SUCH AS ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS, LYRICA, AND CLONAZEPAM. THE PATIENT RESPONDED TO THOSE AND HER ENCEPHALOPATHY CAUSED BY MEDICATIONS GOT BETTER. AN ELECTROENCEPHALOGRAM (EEG) WAS DONE, WHICH ONLY SHOWED SLOWING SUGGESTIVE OF ENCEPHALOPATHY. THE PATIENT DID NOT EXPERIENCE SEIZURES. THE EEG WAS DONE BECAUSE THE PATIENT WAS SHOWING SOME EPISODES OF NON-RESPONSIVENESS. AS SOON AS NARCAN WAS GIVEN AND MEDICATIONS WERE HELD, THE PATIENT¿S RENAL FUNCTION STARTED TO IMPROVE AND THE PATIENT BECAME ORIENTED TO PERSON, PLACE AND TIME. SHE WAS DOING QUITE WELL. AFTER THAT, THE PATIENT WAS STARTED ON PHYSICAL THERAPY EVALUATION TO SIT UP SO THAT SHE COULD QUALIFY FOR ANY ACUTE REHABILITATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 2014-08-14 AND WAS READY FOR ACUTE REHABILITATION, ALONG WITH PUMP ADJUSTMENTS. THE PATIENT¿S HCP HAD BEEN INCREASING THE PUMP DOSE. AS OF (B)(6) 2014, THE PATIENT WAS DOING WELL. HER RENAL FUNCTION HAD IMPROVED AND WAS RETURNING TO NORMAL. HER CREATINE PHOSPHOKINASE (CPK), WHICH WAS ELEVATED,HAD RETURNED TO NORMAL. THE PATIENT¿S FEVER HAD SUBSIDED AND ANTIBIOTICS HAD BEEN DISCONTINUED. THE PATIENT¿S NAUSEA, VOMITING, AND BACLOFEN WITHDRAWAL HAD ALSO RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503145 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R