SYNCHROMED II
Report
- Report Number
- 3004209178-2013-12140
- Event Type
- Injury
- Date Received
- July 23, 2013
- Report Date
- September 26, 2016
- 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
- MN, US
- Reporter Occupation
- PATIENT
Narratives
(B)(4). THE PREVIOUSLY REPORTED CONCLUSION NO LONGER APPLIES TO THIS EVENT.
PRODUCT ID: 8596SC LOT# SERIAL# (B)(4) IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8598A LOT# SERIAL# (B)(4) IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8596SC, SERIAL# (B)(4), EXPLANTED: (B)(6) 2015. PRODUCT ID: 8598A, SERIAL# (B)(4), EXPLANTED: (B)(6) 2015.
(B)(4).
(B)(4).
IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED NAUSEA 24/7. THE SYMPTOMS BEGAN ON (B)(6) 2013 WHEN THE PUMP DOSE WAS FIRST INCREASED. THE PATIENT WAS TOLD THAT THE SIDE EFFECTS WOULD TAKE A WHILE TO GET OUT OF HER SYSTEM. IT WAS NOTED THAT THE MEDICATION WASN¿T HELPING THE PAIN DESPITE INCREASES. ZOFRAN WAS ORDERED AND OVER THE COUNTER MEDICATION FOR NAUSEA WHICH ONLY ¿DROPPED¿ THE NAUSEA FOR AN HOUR. THE FENTANYL WAS REMOVED FROM THE PUMP AT THE END OF JULY. DESPITE REMOVAL OF THE FENTANYL THE PATIENT STILL HAD NAUSEA, LOW GRADE HEADACHE AND A STIFF NECK. A WEEK LATER THE BUPIVACAINE WAS REMOVED FROM THE PUMP. THE PUMP WAS FILLED WITH SALINE. PER THE REPORTER, THE PATIENT HAS NOT HAD ANY SYMPTOMS SINCE THE DRUGS WERE REMOVED. THE PATIENT WAS CURRENTLY TAKING ORAL MEDS. IT WAS NOTED THAT THE PATIENT WAS FUSED FROM L3 TO S1 AND HAD A RIGHT 'RIDE' JOINT FUSION.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY. IT WAS INDICATED THAT AN APPOINTMENT HAD BEEN SCHEDULED FOR ¿(B)(6)-2013¿.
ADDITIONAL INFORMATION REPORTED THAT THE BLOOD PATCH PERFORMED ON (B)(6) 2013 WAS NOT SUCCESSFUL. THE PATIENT HAD BEEN SENT TO THE EMERGENCY ROOM ON (B)(6) 2013 TO RULE OUT MENINGITIS. THE PATIENT WAS DISCHARGED HOME BECAUSE HE WAS NOT SHOWING SYMPTOMS. AN MRI WAS ORDERED AND THE RESULTS WERE NORMAL. A "SPINAL TAP" FROM THE PUMP WAS NORMAL. THE HEADACHES WERE ELIMINATED AFTER FENTANYL AND BUPIVACAINE WERE REMOVED AND HYDROMORPHONE WAS ADDED. IT WAS NOTED THAT THE EVENT WAS POSSIBLY DUE TO THE MEDICATION.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A LOT OF ISSUES RELATED TO DRUG SIDE EFFECTS AND DID NOT HAVE A PUMP PROBLEM, BUT ¿HAS HAD TROUBLE WITH IT¿. THE PATIENT WOULD BE HAVING HER PUMP REMOVED AND ¿IT¿S IN THE PROCESS OF BEING REMOVED¿ BY A NEUROSURGEON. THE MEDICATION SIDE EFFECTS THE PATIENT EXPERIENCED STARTED 72 HOURS AFTER IMPLANT, OR (B)(6) 2013. THE MEDICATIONS PLACED IN HER PUMP AT IMPLANT WERE FENTANYL AND BUPIVACAINE. THE PATIENT HAD TRIED PRIALT, FENTANYL, AND BUPIVACAINE ALONE OR IN COMBINATIONS, BUT THEY CAUSED SEVERE NAUSEA AND THE PATIENT WAS IN BED SEVERAL MONTHS WHEN SHE WAS RECEIVING THE FENTANYL, BUPIVACAINE COMBINATION. WHEN THE PATIENT RECEIVED THE DILAUDID "HYDROCODONE" IT STOPPED HER BOWELS. THE PATIENT NEVER HAD PAIN RELIEF BECAUSE THE DOSE COULD NOT GET TITRATED TO A LEVEL THAT RELIEVED PAIN BECAUSE OF THE SEVERE NAUSEA. CURRENTLY THE PATIENT HAD SALINE IN HER PUMP AND HAD BEEN IN HER PUMP FOR 1 1/2-2MONTHS, AFTER TRYING DILAUDID ONE MORE TIME, WHICH CAUSED HER BOWELS TO STOP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED IN (B)(6) 2015.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUS MEDICATION IN THE PUMP SHUT DOWN THE PATIENT'S BOWELS. IT WAS ALSO STATED THAT THE PATIENT WAS TO MEET WITH HER SURGEON ON (B)(6) 2014 TO START PRIALT. THE PUMP WAS SET TO 5.62MCG/DAY OF NORMAL SALINE ON (B)(6) 2014.
IT WAS REPORTED THAT THE PATIENT HAD SEVERE NAUSEA, STIFF NECK AND A LOW GRADE HEADACHE SINCE IMPLANT. A BLOOD PATCH HAS BEEN SCHEDULED. PER THE REPORTER, THE HEALTHCARE PROFESSIONAL THOUGHT THAT THERE MIGHT BE SOMETHING WITH THE CATHETER. TWO-THREE WEEKS AGO, THE FENTANYL DOSAGE WAS DECREASED TO 6.2 OR 6.5 TO SEE WHAT WOULD HAPPEN AND THE NAUSEA AND HEADACHE WENT AWAY. WHEN THEY RESTARTED THE FENTANYL EVERYTHING CAME BACK; THE PATIENT¿S DOSE WAS CURRENTLY ¿BACK TO 150¿. THE PATIENT WAS NOT GETTING PAIN RELIEF, BECAUSE, THE DOSAGE INCREASE HAS BEEN SLOW. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PHYSICIAN WAS DECREASING THE MEDICATION IN ORDER TO TRY A DIFFERENT MEDICATION.
IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A SPINAL HEADACHE DUE TO AN INTRATHECAL FLUID LEAK. ON (B)(6) 2013 AND (B)(6) 2014, BLOOD PATCHES WERE DONE WITH NO CHANGE IN SYMPTOMS. IN (B)(6) 2013, FENTANYL WAS REMOVED WITH NO CHANGE IN SYMPTOMS. DILAUDID WAS PLACED IN THE PATIENT'S PUMP AND HER HEADACHES STOPPED, BUT IT DIDN'T HELP HER CHRONIC PAIN AND IT CAUSED ITCHING. THE PATIENT WAS SEEKING A SECOND OPINION AND, AT THE TIME OF THIS REPORT, HAD NOT BEEN SEEN BY THE REPORTING HCP SINCE (B)(6) 2014. THE CAUSE OF THE EVENT WAS INDICATED TO BE SOMETHING OTHER THAN THE PUMP, CATHETER, PROGRAMMER, OR DRUG EFFECTS. HOWEVER, THE SPECIFIC CAUSE WAS NOT NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342525 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR | Required Intervention |