SYNCHROMED II
Report
- Report Number
- 3004209178-2013-04674
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- October 11, 2010
- Report Date
- June 20, 2012
- 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
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID: 8709SC SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).
IT WAS REPORTED THAT THE PATIENT WOULD BE OKAY ONE DAY AND THEN THE NEXT DAY SHE WOULD BE REALLY TIGHT. THE PATIENT WAS TAKING SMALL DOSES OF ORAL BACLOFEN BECAUSE SHE WOULD START FEELING ¿PINS AND NEEDLES¿ AND A HEADACHE. THE PATIENT WOULD ACT ¿REALLY WEIRD¿ WITHOUT ORAL BACLOFEN. DYE STUDY WAS DONE AND NO LEAKAGE WAS FOUND. DURING THE CATHETER REPLACEMENT SURGERY, THE DOCTOR FOUND A ¿MASS¿ IN PATIENT WHICH PREVENTED THE DOCTOR FROM ADVANCING THE CATHETER PASS T9. THE DOCTOR LEFT THE CATHETER WHERE IT WAS DURING THAT SURGERY AND ¿IT WORKED FINE.¿ THE PATIENT¿S ARMS WERE TIGHT AND SHE HAD BOTOX. A COMPUTATIONAL TOMOGRAPHY WAS DONE AND CONFIRMED THE ¿MASS.¿ THE DOCTOR TRIED TO DO A SECOND SURGERY TO PUSH THE CATHETER UP BEYOND T9 BY GOING AROUND THE ¿MASS¿. THE DOCTOR ENDED UP PUSHED THE CATHETER TOWARD THE DURA AND ¿IT GOT IN A BAD POSITION.¿ THE REPORTER STATED THAT ¿THE CATHETER WAS NOT IN A PERFECT POSITION, IT WAS OVERFLOWING INTO THIS POCKET AT FIRST IN THE DURA BUT THEN IT WAS OVERFLOWING INTO THE INTRATHECAL SPACE.¿ THE DOCTOR DETERMINED THE ¿MASS¿ WAS NOT AN INFLAMMATORY MASS. IN (B)(6) 2011, THE PATIENT WAS SEEING A PHYSICAL THERAPIST. THE PHYSICIAN THERAPIST HAD THE PATIENT DO TRACTION. THE PATIENT HAD NECK PROBLEMS AND ¿IT MIGHT HAVE DONE SOMETHING TO THE DURA OF THE SPINAL CORD WHERE THAT TIP GOT IN A BAD PLACE.¿ THE HEALTH CARE PROFESSIONAL BELIEVED THAT THE PATIENT WAS GETTING TOLERANT TO THE MEDICINE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE CATHETER WAS REVISED IN (B)(6) 2012. THERE WAS NOTHING WRONG WITH THE CATHETER. THE PLACEMENT WAS ¿NOT VERY GOOD.¿ IT WAS NOTED THAT THERE WAS NO ¿MASS.¿ THE SYMPTOM WAS LACK OF EFFECT. THE PATIENT WAS SEEN IN (B)(6) 2012 AND WAS ¿DOING WELL AND NOT HAVING ANY ISSUES.¿
ADDITIONAL REVIEW WAS CONDUCTED. SOME INFORMATION REPORTED BELOW WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT # 3004209178-2011-09989. THE BELOW INFORMATION CONTAINS PREVIOUSLY REPORTED INFORMATION FOR CLARITY. IT WAS REPORTED THAT THE PATIENT HAD A TYPE OF OBSTRUCTION IN HER SPINE AND WHEN THE SURGEON TRIED TO ADVANCE THE NEW CATHETER BEYOND IT, HE WAS NOT SUCCESSFUL. IT WAS NOTED THAT THE TIP OF THE CATHETER WAS IN ¿THIS TYPE OF SAC OF FIBROUS TISSUE.¿ ON (B)(6) 2010, THE PATIENT¿S PUMP AND CATHETER WERE REPLACED. THE REPLACEMENT OCCURRED BECAUSE THE PUMP HAD REACHED END OF LIFE AND THE PATIENT ¿REQUIRED A NEW CATHETER PLACEMENT.¿ DURING SURGERY, A NEW CATHETER WAS PLACED INTO THE DURA AT L3-4 AND ADVANCED TO THE LEVEL OF ABOUT T10-11, WHICH WAS VERIFIED USING FLUOROSCOPY. A NEW PUMP POCKET WAS CREATED AFTER THE OLD PUMP WAS REMOVED. THE CATHETER WAS TUNNELED TO THE PUMP AND CONNECTED TO THE PUMP USING A SUTURELESS CONNECTOR. THE PUMP WAS FILLED WITH 40 MLS OF BACLOFEN 2000 MCG/ML CONCENTRATION. THE RATE WAS SET AT 280 MCG/DAY, WHICH WAS UNCHANGED FROM PRIOR TO SURGERY. ON FOLLOW-UP AFTER SURGERY, IT WAS NOTED THE PATIENT ¿HAD ISSUES REGARDING HER BACLOFEN TREATMENT AND WHETHER OR NOT THE CATHETER [WAS] ADEQUATELY POSITIONED TO TREAT HER SPASTICITY.¿ ON (B)(6) 2011, THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO REPLACE THE CATHETER FROM T11 TO A HIGHER LEVEL IN THE SPINE: T2, T3, OR T4. THE HCP NOTED THAT WHEN THE EXISTING CATHETER WAS PLACED, ADHESIONS WERE NOTED AROUND T12. THE HCP PLANNED TO BYPASS THE ADHESION AREA WITH A NEW CATHETER AND PLACE THE TIP AT HIGHER LEVEL IN THE SPINE. THE PATIENT¿S PREVIOUS MRIS DID NOT REVEAL ANY MASS AT THE LEVEL OF T11 NOR DID A MYELOGRAM SHOW ANY MASS, BUT DYE WOULD NOT PASS ABOVE THE AREA. DURING SURGERY, THE HCP RAN INTO THE ADHESIONS AT T11. THE HCP TRIED TO STEER THE CATHETER AROUND ALL ASPECTS OF THE INTRATHECAL SAC BUT WAS NOT ABLE TO ADVANCE THE CATHETER PAST T11. THE HCP THEN TRIED TO ADVANCE A NEEDLE INTO THE T6/T7 REGION AND WAS ABLE TO GET INTO THE INNER SPACE, BUT NO CEREBROSPINAL FLUID RETURNED. THE HCP ATTEMPTED ONCE MORE AT L3/L4 ON THE CONTRALATERAL SIDE TO TRY AND ADVANCE THE CATHETER, BUT AGAIN ENCOUNTERED ¿SIGNIFICANT OBSTRUCTION¿ IN THE T11 REGION AT THE NECK LEVEL OF THE OLD CATHETER. THE EXISTING CATHETER WAS LEFT IN POSITION ¿SINCE IT WAS DELIVERING DRUG ADEQUATELY AND DID NOT FEEL THAT IT WAS OBSTRUCTED IN ANY WAY.¿ THE (B)(6) 2011 SURGERY WAS INTENDED TO ¿PLACE THE CATHETER IN A MORE OPTIMAL LEVEL IN THE MID-UPPER THORACIC REGION, WHICH MIGHT HAVE IMPROVED HER U PPER EXTREMITIES SPASTICITY.¿ THE EXISTING CATHETER WAS RE-ANCHORED AND THE AREA WAS CLOSED; THERE WAS NO EVIDENCE OF ANY CEREBROSPINAL FLUID LEAK. ADDITIONAL INFORMATION WAS REPORTED REGARDING THE (B)(6) 2011 ATTEMPTED CATHETER REVISION. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO PUSH THE CATHETER BEYOND A ¿MASS.¿ IT WAS NOTED THAT THE MASS HAD BEEN INITIALLY DETECTED IN 2004 AND ALSO DURING THE 2010 PUMP REPLACEMENT. THE MASS WAS SEEN ON CT SCAN. THE PHYSICIAN TRIED FOR 2 HOURS TO PUT A NEW CATHETER IN TO GET AROUND THE MASS, BUT COULD NOT. THE NEW CATHETER WAS PULLED, AND THE OLD CATHETER WAS LEFT IN ALBEIT STILL WAS NOT IN A GOOD POSITION. THE TIP WAS IN THE DURA, AND WAS ¿FILLING A LITTLE POCKET AND ALL OVERFLOWING INTO THE INTRATHECAL SPACE¿, BUT THE PHYSICIAN FELT THE PATIENT WAS GETTING WHAT SHE ADEQUATELY NEEDED. THE TIP WAS ALSO DESCRIBED AS BEING IN A ¿SAC OF FIBROUS TISSUE.¿ THE LAST DYE STUDY SHOWED THAT THE ¿DYE WAS GOING AROUND THE MASS.¿ IT WAS ALSO NOTED THAT THE PHYSICIAN FELT THE PATIENT WAS ¿GETTING USED TO THE DOSE¿ OR ¿TOLERANT¿, AND THAT THE PATIENT SHOULD GET A HIGHER DOSE, BASED ON THE OUTCOMES OF THE DYE STUDY AND NO VOLUME DISCREPANCIES. IT WAS NOTED THAT THE MASS WAS STILL THERE. IT WAS REPORTED THAT THE PATIENT¿S ARMS WERE STILL TIGHT AND THE PATIENT GOT BOTOX. IT WAS UNSURE WHAT THE MASS WAS, BUT IT WAS NOTED THAT THE PHYSICIAN FELT IT WAS NOT AN INFLAMMATORY MASS. IT WAS THOUGHT THAT A PREVIOUS CATHETER POSITIONED AT T3 MIGHT HAVE CAUSED THE ¿ADHESIONS.¿ IT WAS ALSO NOTED THAT THE PATIENT COULD HAVE ¿SCAR TISSUE¿ AND ¿WHO KNOWS WHAT COULD HAVE CAUSED¿ THE MASS. IT WAS NOTED THAT THE PATIENT¿S TINGLING WENT AWAY AND THERE WERE NO RESIDUAL SYMPTOMS, SO THE PHYSICIAN ¿SAID NOT TO WORRY ABOUT IT.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN ¿THROUGH 2 YEARS OF ¿HELL¿ SINCE SHE RECENTLY HAD A CATHETER REVISION DUE TO ISSUE WITH THE CATHETER TIP NOT BEING PLACED IN THE RIGHT PLACE.¿ IT WAS FELT THE PATIENT NEEDED A LITTLE MORE MEDICATION. IT WAS REPORTED THE PATIENT RECENTLY HAD HER CATHETER REVISED BY PHYSICIAN IN (B)(6); THE EXACT DATE WAS NOT PROVIDED. THE PATIENT STARTED TO SEE A NURSE PRACTITIONER WHO WORKS WITH HER ORIGINAL PHYSICIAN. ADDITIONAL INFORMATION REPORTED THAT THERE WAS NOTHING WRONG WITH THE CATHETER; THE PLACEMENT WAS JUST NOT VERY GOOD. THE PATIENT HAD LIORESAL IN THE PUMP AT THE TIME. THE PATIENT HAD A SURGERY ON (B)(6) 2012 WHERE THERE CATHETER WAS REPLACED. THE INFORMATION SURROUNDING THIS REPLACEMENT SURGERY CAN BE FOUND UNDER MANUFACTURER REPORT # 3004209178-2011-09989. THE PATIENT WAS SEEN IN (B)(6) 2012 AND WAS DOING WELL. HE WAS NOT HAVING ANY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301807 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00022 YR | Required Intervention |