SYNCHROMED II
Report
- Report Number
- 3004209178-2014-11302
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 19, 2014
- Report Date
- June 3, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THERE WAS AN INCREASE IN PAIN AT THE (B)(6) 2013 REFILL. THERE WAS A DECREASE IN PAIN INTENSITY ON (B)(6) 2013. THE PUMP WAS REFILLED WITH 20 MILLILITERS OF ¿CMPD.¿ IT WAS NOTED THE PATIENT SUFFERED FROM LOW BACK PAIN WITH RADICULAR SYMPTOMS AS WELL AS ARACHNOIDITIS. THE PATIENT HAD DONE WILL WITH INTERVENTIONAL PAIN MANAGEMENT IN CONJUNCTION WITH THE PUMP. THE PUMP WAS REFILLED AND REPROGRAMMED TO REFLECT A CHANGE IN VOLUME. THE PROGRAMMING WAS ESCALATED BY ¿ANOTHER 15%.¿ THE NEW SETTINGS WERE 3.7 MICROGRAMS (MCG) PRIALT PER DAY, 457 MCG CLONIDINE PER DAY, 4.2 MILLIGRAMS (MG) DILAUDID PER DAY AND 8 MG MARCAINE PER DAY. IT WAS DECIDED TO PROCEED WITH A CT MYELOGRAM AND THE PATIENT WAS TO BE SEEN AT THE NEXT VISIT TO RULE OUT SURGICALLY CORRECTABLE CAUSES. IT WAS REPORTED THE PATIENT HAD ¿INCIDENTS¿ FOR THE LAST TWO NIGHTS PRIOR TO (B)(6) 2013 WITH THINKING PEOPLE WERE AFTER HER. THE PATIENT WAS CONFUSED AND DAZED. THE PATIENT WAS IN REHAB AND WAS BEING TAKEN OFF OF OXYCONTIN AND DECREASING THE DOSE OF CLONIPIN. LATER THAT DAY, IT WAS REPORTED THE CONFUSION WAS NOT CAUSED BY THE DRUGS IN THE PUMP. THE PATIENT WAS TOLD SHE COULD COME IN TO HAVE THE PUMP DECREASED BY 20% IF REQUESTED. THE NEXT DAY IT WAS REPORTED THE PATIENT WAS IN REHAB FOLLOWING TOTAL RIGHT HIP REPLACEMENT 11 DAYS EARLIER. THE PATIENT WAS IMPROVING AND NOT CONFUSED. THE CLONIPIN HAD BEEN DISCONTINUED AND THE PATIENT WAS DOING WELL WITH REHAB. ON (B)(6) 2014 IT WAS NOTED THE PATIENT COMPLAINED OF HEARING VOICES WITH AN INCREASE IN PRIALT SO THE PRIALT WAS DECREASED. THE PATIENT WAS STILL HEARING WHITE NOISE, BUT THE PAIN HAD SIGNIFICANTLY INCREASED SINCE THE DECREASE IN PRIALT. IT WAS NOTED THAT PRIALT HAD ORIGINALLY BEEN ADDED BECAUSE THE MIX WITHOUT PRIALT WAS NOT EFFECTIVE ENOUGH. IT WAS NOTED ON (B)(6) 2013 THE PUMP HAD CONTAINED PRIALT, CLONIDINE, HYDROMORPHONE, AND BUPIVACAINE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD HIP SURGERY PRIOR TO BEING A PATIENT AT THE PAIN CENTER. THE HIP SURGERY HAD NOTHING TO DO WITH PRIALT THERAPY.
ADDITIONAL INFORMATION RECEIVED PROVIDED TELEMETRY STRIPS. PER TELEMETRY STRIPS FROM WHEN THE PUMP WAS INTERROGATED ON (B)(6) 2013, THE DOSE WAS DECREASED BY ONE PERCENT AND THE CONCENTRATIONS OF THE CLONIDINE INCREASED WHILE THE HYDROMORPHONE AND BUPIVACAINE CONCENTRATIONS DECREASED. PER A NOTE FROM THAT DAY, (B)(6) 2013, THE PATIENT'S PAIN INTENSITY HAD DECREASED; THEIR ANALGESIC USE WAS THE SAME AND THEIR MOBILITY AND SLEEP HAD INCREASED. THE PATIENT'S LOWER BACK PAIN WAS RATED AT 5 AND ADDITIONAL PAIN WAS RATED AT 7 OR 8. PER TELEMETRY STRIPS FROM WHEN THE PUMP WAS INTERROGATED ON (B)(6) 2013, THE DAILY DOSE WAS INCREASED 14 PERCENT. THE CLONIDINE, HYDROMORPHONE AND BUPIVACAINE CONCENTRATIONS WERE ALL DECREASED. PER A NOTE FROM THAT DAY, THE PATIENT HAD AN INCREASE IN PAIN INTENSITY AND A DECREASE IN THEIR MOBILITY AND SLEEP. A NOTE PROVIDED, DATED (B)(6) 2014, STATED THE PATIENT WANTED THE PUMP INCREASED AS THEIR PAIN WAS RATED AT 7 OUT OF 10. IT HAD STARTED ESCALATING THAT PREVIOUS SATURDAY HOWEVER THE PATIENT WASN'T HEARING VOICES ANYMORE, JUST STATIC NOISE. THE PATIENT WANTED TO KNOW IF THE PRIALT WAS REMOVED THEN WHAT OTHER CHOICES WERE THERE. THE PATIENT WAS INFORMED THE HCP WOULD BE CONTACTED TO SEE WHAT OPTIONS WERE AVAILABLE. A NOTE WAS PROVIDED FROM (B)(6) 2014 AT WHICH TIME THE HEALTH CARE PROVIDER (HCP) WAS NOTIFIED OF THE PATIENT COMPLAINING OF HEARING VOICES AFTER AN INCREASE IN THE PRIALT. THE PRIALT WAS THEN DECREASED. THE PATIENT WAS STILL AS PREVIOUSLY REPORTED HEARING THE WHITE NOISE BUT HER PAIN HAD SIGNIFICANTLY INCREASED SINCE. THE HCP WAS AWARE. THE NURSE WAS TO CALL THE PATIENT AT MORNING AND FIND OUT IF SHE WANTED TO CONTINUE WITH PRIALT OR REMOVE IT. IT WAS AGAIN NOTED THE PRIALT HAD BEEN ADDED BECAUSE WITHOUT IT, IT WASN'T EFFECTIVE ENOUGH. PER TELEMETRY STRIPS FROM WHEN THE PUMP WAS EXAMINED ON (B)(6) 2014, THE DOSE WAS INCREASED 10 PERCENT. A NOTE FROM THEN INDICATED THE PATIENT'S PAIN INTENSITY, ANALGESIC USE, MOBILITY AND SLEEP WERE THE SAME. THEIR LOWER BACK PAIN WAS RATED AT A 7 OR 8 AND WAS DESCRIBED AS SHARP, STABBING AND SOMETIMES DULL. THE PATIENT'S VITALS THAT DAY WERE WITHIN NORMAL LIMITS. A TEAM PROGRESS NOTE WAS PROVIDED FROM (B)(6) 2014 AT WHICH TIME THE PATIENT STATED THE PRIALT WAS GOING "OK" AND SHE DIDN'T WANT TO INCREASE HER DOSAGE AT THAT TIME. HER PAIN LEVEL WAS AT A 7 WITH THE "IMPENDING RAIN COMING" AT THE TIME OF THE REPORT. THE PATIENT DENIED SIDE EFFECTS WITH THE PRIALT. THEN BACK ON (B)(6) 2014, A 5 PERCENT INCREASE IN THE DOSE HAD OCCURRED. A NOTE WAS PROVIDED FROM (B)(6) 2014, AT WHICH TIME THE PATIENT RATED THEIR PAIN AT A 4 OUT OF 10 IN THE LOWER BACK. ANOTHER NOTE WAS PROVIDED FROM (B)(6) 2014 AT WHICH TIME THE PATIENT HAD A DECREASE IN PAIN INTENSITY AND AN INCREASE IN SLEEP AND MOBILITY. THE PATIENT'S PAIN SCORE WAS LISTED AS A 3 AND 7 WITH THE LOCATION BEING THEIR BACK. TELEMETRY STRIPS WERE ALSO PROVIDED FROM (B)(6) 2014 AT WHICH TIME A 12 PERCENT INCREASE IN THE DAILY DOSE HAD OCCURRED, THE PRIALT CONCENTRATION WAS ALSO INCREASED. A TEAM PROGRESS NOTE WAS ALSO PROVIDED FROM (B)(6) 2014 AT WHICH TIME THE PATIENT RATED THEIR LOWER BACK PAIN AT A 6 OR 7 OUT OF THEN WITH NO SIDE EFFECTS FROM THE PRIALT. THE PATIENT WANTED A 10 PERCENT INCREASE AT THE NEXT REFILL, WHICH THEN OCCURRED AS REPORTED ON (B)(6) 2014. AS OF (B)(6) 2014, A TEN PERCENT DOSE INCREASE OCCURRED WITH PRIALT, CLONIDINE, HYDROMORPHONE AND BUPIVACAINE IN THE DEVICE. THE PRIALT CONCENTRATION WAS CURRENTLY 15.7MCG/ML AT A DOSE OF 6.006MCG/DAY. PER A NOTE FROM (B)(6) 2014, THE PATIENT HAD IN INCREASE IN PAIN INTENSITY AND A DECREASE IN SLEEP. THEIR PAIN WAS RATED AT 5 OUT OF 10 ON A 0 TO 10 PAIN SCALE WITH 10 BEING THE WORST. VITAL SIGNS WITHIN NORMAL LIMITS WERE PROVIDED FROM THE VISIT THAT DAY. ADDITIONAL INFORMATION WAS PROVIDED HOWEVER IT WAS ILLEGIBLE; ADDITIONAL CLARIFYING INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL CLARIFYING INFORMATION REGARDING THE TELEMETRY STRIPS AND HEALTH CARE PROVIDER (HCP) NOTES PREVIOUSLY PROVIDED WERE OBTAINED. ON (B)(6) 2013, A LESI (LUMBAR EPIDURAL STEROID INJECTION) WAS PERFORMED IN THE PATIENT'S LUMBAR SITE. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT'S VITAL SIGNS FROM THAT DAY APPEARED TO BE WITHIN NORMAL LIMITS. IT WAS THEN NOTED IN THE NOTES SECTION FOR THAT DAYS VISIT THAT POST PROCEDURE THE PATIENT WAS "WALKING ABOUT AND REPORTS 'NUMB' FEELING IN LEGS". PER A NOTE ON (B)(6) 2013, THE PATIENT'S PAIN WAS RATED AT 7 OUT OF 10 IN THEIR RIGHT HIP. THE PATIENT'S VITAL SIGNS THAT DAY APPEARED WITHIN NORMAL LIMITS. PER NOTE ON (B)(6) 2014, THE PATIENT'S PAIN INTENSITY HAD INCREASED AND THEIR MOBILITY AND SLEEP HAD DECREASED. THEIR PAIN WAS RATED AT 4 OUT OF 10 IN THEIR LEFT HIP. THE DOSE WAS DECREASED 10 PERCENT THAT DAY. THEIR VITAL SIGNS THAT DAY WERE PROVIDED APPEARED TO BE WITHIN NORMAL LIMITS. PER A NOTE FROM (B)(6) 2014, THE LEGIBLE VITAL SIGNS APPEARED TO BE WITHIN NORMAL LIMITS. FURTHER INFORMATION REMAINED ILLEGIBLE FROM THAT DAYS NOTE. PER THE NOTE THAT WAS WRITTEN ON (B)(6) 2014, THE LEGIBLE VITAL SIGNS APPEARED TO BE WITHIN NORMAL LIMITS. PER THE NOTE THAT WAS WRITTEN ON (B)(6) 2014, THE PAIN THAT HAD BEEN RATED AT A 5/10 WAS IN THE PATIENT'S LOWER BACK AND LEGS. THE PATIENT'S VITAL SIGNS FROM THAT DAY APPEARED TO BE WITHIN NORMAL LIMITS. IT WAS NOTED THERE WERE NO SIGNS OF A POCKET FILL. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER NOTED THE HCP'S OFFICE WASN'T GOING TO COOPERATE IN TERMS OF GATHERING ADDITIONAL CLARIFYING LEGIBLE INFORMATION. THE CHARTS HAD BEEN MAILED BECAUSE THE DOCUMENTS IN THE CHART WERE "SO BAD". THE OFFICE HAD GOTTEN PERMISSION FROM THE PATIENT'S FOR THE DEVICE MANUFACTURER REPRESENTATIVE TO GO THROUGH THE CHART AND PULL OUT WHAT THEY NEEDED BECAUSE THE HCP'S WOULD NOT DO IT. NO FURTHER INFORMATION WAS AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROVIDER (HCP) MEDICALLY CONFIRMED THE ADVERSE EVENT BUT NOTED THE DATE IT WAS REPORTED WAS 2014-(B)(6). THE CIRCUMSTANCES OF THE ADVERSE EVENT OR INCIDENT WERE NOTED TO BE AN INCREASE IN THE PRIALT DOSE IN THE PAIN PUMP. THIS CAUSED AUDITORY HALLUCINATIONS (VOICES) SO THE HCP DECREASED HER DOSE AND THE VOICES REPORTEDLY SUBSIDED. IT WAS ALSO REPORTED THE PATIENT WAS ¿TOLERANT OF PRIALT TO PRESENT, 2014-(B)(6)¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339412 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Other |