SYNCHROMED II
Report
- Report Number
- 3004209178-2013-06765
- Event Type
- Injury
- Date Received
- April 23, 2013
- Report Date
- March 27, 2013
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID: 8711 SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709SC SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER (B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THERE WAS A CATHETER LEAK. A DYE STUDY WAS COMPLETED ON (B)(6) 2013 WHICH SHOWED A MINOR LEAK AT THE CATHETER CONNECTION. REPORTER INDICATED, THE PATIENT WAS GOING THROUGH WITHDRAWAL AND UNDERDOSE. THE MEDICATION IN THE PUMP WAS BACLOFEN. PATIENT STATED "THERE WERE A LOT OF FAILURES TO WITNESS MY GREAT BASIC SYMPTOMS OF WITHDRAWAL THAT HAVE HAD ME AT LIFE THREATENING RISKS FOR THE LAST 6-8 WEEKS." THE PATIENT FIRED THE HEALTHCARE PROVIDER (HCP) BECAUSE "HE FAILED" HER AND HE LEFT HER "FOR DEAD 6 WEEKS AGO - LITERALLY". THE CATHETER "FAILED" 6-8 WEEKS PRIOR TO REPORT, SOMETIME IN (B)(6). THEY HAD FILLED AND INCREASED THE PUMP ON (B)(6) 2013 AND APPROXIMATELY 2 WEEKS LATER, THE PATIENT WENT BACK TO THE HCP WITH SEVERE SPASTICITY, RIGIDITY AND RETURN OF SYMPTOMS. THE HCP DID NOT ASK THE PATIENT IF SHE WAS ITCHING, WHICH SHE WAS, AND JUST BUMPED UP THE DOSE QUITE A BIT FOR THE PATIENT INSTEAD. THE HCP INDICATED TO THE PATIENT AT THAT TIME THAT USUALLY THEY ONLY DO A LITTLE INCREASE, AND DIRECTED THE PATIENT TO HAVE AN X-RAY IN TWO WEEKS. THE PATIENT WAS AT 80 MG A DAY, "LIKE 86" AND THE HCP "BUMPED IT UP TO 90'S WHICH DID A LITTLE BIT OF GOOD", ALTHOUGH, THE PATIENT STILL HAD SPASTICITY BUT NOT TO THE EFFECT AS WHEN THEY DID THE DYE STUDY. THE PATIENT "ADMITTED HERSELF" TO EMERGENCY ROOM 2 WEEKS BEFORE THE DYE STUDY. THE PATIENT INDICATED TO THE HOSPITAL HCP'S THAT EITHER THE PUMP WAS NOT WORKING OR IT COULD BE A BLOOD CLOT AS THE PATIENT HAD AN INTER VENA CAVA FILTER AND WAS ON COUMADIN. THE LAST TIME THE PATIENT HAD A CLOT, THERE WAS AN INCREASE OF SPASTICITY AND EDEMA. AT THAT TIME, THERE WERE NO NEW BLOOD CLOTS SO IT WAS ASSUMED THAT MEANT IT WAS THE PUMP, BUT THE PEOPLE "AT THE ER DIDN'T DO ANYTHING WITH THE PUMP". THE PATIENT CALLED THE ORIGINAL HCP "WHO TOTALLY IGNORED HER AND TOLD HER TO WAIT 2 WEEKS". THE HCP LEFT THE PATIENT "WAITING FOR MONTHS". THE PATIENT HAD SEVERE PAIN "LIKE HAVING BIRTH CONTRACTIONS" IN THE LEGS AND WASN'T ABLE TO SLEEP, AND HAD SEVERE CRAMPS. PER THE PATIENT, NO ONE SEEMED TO KNOW ABOUT THE SPASTICITY AND ITCHING. THE PUMP WAS BUMPED UP AGAIN, WHICH STOPPED THE ITCHING AND THE PATIENT WAS TOLD TO WAIT 10 DAYS AND TO GO OFF THE COUMADIN. ON (B)(6) 2013 THE HCP ORDERED A DYE STUDY. THE DYE STUDY SHOWED THERE IS A MINOR LEAK, WHERE THE 2 CATHETERS CONNECT. THE PATIENT ALSO TOLD THE HPC THAT SHE THOUGHT HER PUMP FLIPPED. SHE WAS IN THE WHEEL CHAIR AND BENT OVER TO REACH SOMETHING AND FELT LIKE IT FLIPPED AND SHORTLY AFTER THAT SHE FELT LIKE IT WAS NOT FUNCTIONING PROPERLY. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE POSSIBLE FLIPPED PUMP, SO IT WAS NOT KNOWN IF THE PUMP HAD FLIPPED. THE PATIENT STATED THAT THE SPASTICITY WAS SO BAD THEY LITERALLY HAD TO PULL THE PATIENT'S KNEES AWAY FROM HER CHEST, WHICH LEFT THE PATIENT IN TEARS TO GET THE X-RAY MACHINE AROUND THE STOMACH FOR THE DYE STUDY. ON (B)(6) 2013, A CATHETER REVISION TOOK PLACE AND THE ENTIRE CATHETER WAS REPLACED DUE TO THE LEAK. FOLLOWING THE PROCEDURE, THE PATIENT STATED THAT THE HCP ORDERED THE DOSE AFTER SURGICAL REVISION TO BE AT 50. THE PATIENT WAS UPSET AT THIS DOSE, NOTING THERE WAS AN EXPECTATION OF BEING IN PAIN THE FOLLOWING DAY AS SOON AS THE ANESTHESIA WORE OFF. THAT NIGHT SHE STARTED ITCHING RIGHT AWAY AND BEGAN HAVING SPASMS, WAS RIGID, COULD NOT STAND, HAD TO WEAR DIAPERS AND WAS IN TERRIBLE PAIN ALL NIGHT. THE PATIENT CALLED THE HCP THE NEXT DAY TELLING HIM SHE HAD TO BE SEEN. THE PATIENT WAS TOLD THE HCP WAS NOT IN, BUT TO GO IN AND THEY WILL BUMP THE DOSE UP TO "AROUND HIGH 80'S". THAT DAY THEY SET IT AT "83 SOMETHING" AND THE PATIENT WAS MUCH BETTER. PATIENT INDICATED SHE BELIEVED FOR 2 DAYS SHE DID NOT HAVE ANY BACLOFEN AND DIDN'T THINK THE DOSING WAS APPROPRIATE. THE PATIENT INDICATED WHEN SHE STATED "OH MY FACE IS SO ITCHY", IT WAS THEN NOTED THAT THE SITUATION WAS SERIOUS AND THAT THE PATIENT WAS IN WITHDRAWAL. THE PATIENT NOTED DISSATISFACTION WITH ALL OF THOSE INVOLVED IN HER CARE, STATING THAT THEY "FAILED TO RECOGNIZE THE BASIC WITHDRAWAL SYMPTOMS OF BACLOFEN AND THE SERIOUSNESS OF IT". THE PATIENT NOTED THAT IN ADDITION TO THE ITCHING, HER BLOOD PRESSURE HAD BEEN INCREASED. THE PATIENT REPORTED, THE PUMP WAS DELIVERING LIORESAL (BACLOFEN). IT WAS LATER REPORTED THAT SINCE HAVING THE DOSE INCREASED TO 83.9 THE WEEK PRIOR, THE PATIENT WAS FEELING "A LITTLE BIT OVERDOSED", SO THEY WERE GOING TO DROP THE DOSE A BIT. THE PATIENT FELT FOR 2 OR 3 DAYS WOOZY AND LETHARGIC. THE REPORTER INDICATED THEY WERE TITRATING THE DOSE TO GET TO THE APPROPRIATE LEVEL FOR THE PATIENT. IT WAS NOTED, THE PATIENT WAS IN THE PROCESS OF CHANGING PUMP MANAGEMENT HCP'S. IT WAS LATER REPORTED THAT REGARDING THE PATIENT'S STATUS AND THERAPY, THE PATIENT "WAS HAPPY" WHEN THE REPORTER AND THE PATIENT LAST MET A WEEK AFTER THE EVENT.
IT WAS FURTHER REPORTED THAT AT THE TIME THE PATIENT EXPERIENCED HER WITHDRAWAL SHE ALSO HAD AN ALTERED MENTAL STATE. SHE WAS SENSITIVE TO DOSE INCREASES AND HAD MANY DOSE INCREASES OVER THE YEARS.
IT WAS LATER REPORTED THAT THE PATIENT'S CATHETER BROKE. THE PATIENT CONSULTED WITH A NEW NEUROSURGEON ABOUT HER PUMP AND CATHETER.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT THOUGHT SHE THOUGHT SHE ¿PULLED HER TUBE OUT¿ WHEN SHE WAS BENDING OVER IN JANUARY. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) BECAUSE SHE WAS IN SO MUCH PAIN. THE PATIENT WAS CHECKED FOR A BLOOD CLOT. THE PATIENT WAS TOLD SHE DID NOT HAVE A BLOOD CLOT AND WAS SENT HOME. THE PATIENT HAD A SIMILAR FEELING AS WHEN SHE HAD A BLOOD CLOT IN 2008. THE PATIENT HAD AN X-RAY IN MARCH AND THE PATIENT WAS TOLD THERE WAS NOTHING WRONG. AT THAT TIME, THE PATIENT WAS FALLING 2-3 TIMES A DAY, TAKING AN HOUR TO GET OFF THE FLOOR. THE PATIENT HAD A DYE STUDY ON (B)(6) AND, AT THIS TIME, THE PATIENT ¿WAS SUICIDAL IF THE PAIN DID NOT STOP¿. THE PATIENT WAS PRESCRIBED ORAL ZANAFLEX AFTER THIS APPOINTMENT. THE PATIENT WAS IN BACLOFEN WITHDRAWAL FOR TWO MONTHS. THE PAIN WAS ¿A 15-20¿ ON A PAIN SCALE OF 1-10. WHEN THE PATIENT ATTEMPTED TO TRANSFER, SHE WOULD FALL. SHE HAS BEEN IN A POWER CHAIR SINCE THIS INSTEAD OF A MANUAL CHAIR OR A WALKER. IF THE DOSE IS INCREASED BY 2MCG A DAY, THE PATIENT FELT ¿WOOZY¿. IT TAKES A WEEK FOR HER TO FEEL NORMAL AGAIN. THE PATIENT HAS LOST ENERGY AND MUSCLE MASS. THE PATIENT WAS WITHOUT BACLOFEN DURING THE 5½ HOURS OF THE CATHETER REVISION. WHEN SHE WENT HOME FROM THE SURGERY, HER PAIN WAS WORSE THAN IT WAS WHEN SHE WENT IN. THE PATIENT WENT BACK THE NEXT DAY. HER DOSE WAS INCREASED FROM 50 TO 80. IT TOOK A COUPLE DAYS FOR IT TO ¿SINK IN¿ AND THE PATIENT FELT ¿WOOZY¿, BUT THE PATIENT WAS FEELING OKAY AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174314 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |