SYNCHROMED II
Report
- Report Number
- 3004209178-2013-12118
- Event Type
- Injury
- Date Received
- July 22, 2013
- Report Date
- June 28, 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER; PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
IT HAD BEEN REPORTED AS OF (B)(6) 2013, FOR THE "LAST COUPLE OF DAYS" THE PATIENT HAD BEEN NAUSEATED, THROWING UP AND SINCE THE DAY PRIOR STARTED "FEELING KIND OF FUNKY". THE PATIENT HAD TRIED CALLING HER HEALTH CARE PROVIDER (HCP) HOWEVER THEY WERE NOT OPEN AT THE TIME. THE PATIENT WAS CONSIDERING TAKING HERSELF TO THE EMERGENCY ROOM. THE PATIENT WAS NOT HEARING ANY ALARMS. IT WAS NOTED WHEN THE PATIENT WOULD GO AND GET ADJUSTED "EVERY NOW AND THEN" SHE WOULD GET THESE "SICK TO MY STOMACH SYMPTOMS. THE PATIENT REPORTEDLY WOULD GET VERTIGO ALL OF A SUDDEN, AND IF SHE STOOD UP QUICKLY OR IF SHE DIDN'T STAND UP QUICK SHE WOULD GET DIZZY AND "IT'S LIKE THINGS START SPINNING AND I JUST DON'T KNOW IF IT'S THIS". THE PATIENT DIDN'T KNOW IF THEY WERE HAVING A "TIA OR WHAT". IT WAS NOTED THE "SICK TO STOMACH SYMPTOMS THAT WERE OCCURRING AS OF (B)(6) 2013 "USUALLY DOESN'T LAST LIKE THIS". THE PATIENT'S LAST REFILL HAD BEEN TWO MONTHS AGO AND HER NEXT ONE WAS (B)(6) 2013. IT WAS NOTED THE WEEK PRIOR TO (B)(6) 2013 THE PATIENT FLEW ON A PLANE. THE PATIENT HAD BEEN SKIING BUT HAD NO FALLS OR TRAUMA. IT WAS ALSO REPORTED THE PATIENT STATED, "I HAVEN'T HAD ANY ISSUES, I LOVE THIS THING, IT'S WONDERFUL". IT WAS THEN REPORTED "SOMETIMES IT'S WET INSIDE; IT'S JUST AN ODD SENSATION. AROUND THE PUMP AREA". THE FEELING HAPPENED "EVERY NOW AND THEN AND I DON'T KNOW IF I MAYBE SIT WRONG OR IF I PINCH IT OR IT GOES TO SLEEP". IT WAS LATER REPORTED AS OF (B)(6) 2013 THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HCP OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN UPCOMING APPOINTMENT ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED FOLLOWING THE PATIENT BEING SWITCHED TO SIMPLE INFUSION ON (B)(6) 2011, OVER THE NEXT FOUR MONTHS THE HYDROMORPHONE DOSE WAS INCREASED WHILE THE BUPIVACAINE DOSE WAS DECREASED. ON (B)(6) 2011 A PERSONAL THERAPY MANAGER (PTM) WAS ADDED. OVER THE NEXT YEAR THE HYDROMORPHONE AND BUPIVACAINE DOSES WERE SLOWLY INCREASED. IT WAS NOTED UP UNTIL THAT POINT THE CLINIC NOTES WERE "SKETCHY" AND DID NOT PROVIDE CLINICAL EXPLANATION TO DOSE ESCALATION NOR WHETHER THE PATIENT WAS EXPERIENCING SIDE EFFECTS. IT WAS REPORTED THERE WAS NO DOCUMENTED RESIDUAL PUMP VOLUME AT THE TIME OF REFILL. THEN STARTING ON (B)(6) 2013 AT A REFILL THERE WAS SUBSTANTIALLY BETTER DOCUMENTATION AT THE TIME OF THE REFILL AND CLINIC VISITS. AT THAT VISIT, THE CLINIC NOTE STATED THE ASPIRATED VOLUME WAS LESS THAN EXPECTED BY 8ML (EXPECTED 11.7ML VERSUS ACTUAL 3ML). A ROTOR STUDY WAS PLANNED ON (B)(6) 2013. THE STUDY SHOWED THE PUMP TUBING TO BE INTACT, THERE WAS NO LEAKAGE OF CONTRAST IDENTIFIED AND THE CATHETER TIP WAS NOTED AT T10. ON (B)(6) 2013 THE PATIENT RECEIVED A REFILL. THE EXPECTED RESIDUAL VOLUME WAS 7.1ML WHILE THE ACTUAL WAS 0.5ML. THE PLAN WAS TO RECHECK THE VOLUMES IN TWO WEEKS. IT WAS NOTED AGAIN THE CLINIC NOTES DID NOT DISCUSS PATIENT SYMPTOMS OR COMPLAINTS AT THE REFILL VISIT. THEN ON (B)(6) 2013 THE PATIENT HAD A PUMP CHECK WHERE THE EXPECTED RESIDUAL VOLUME WAS 34.2 AND THE ACTUAL MEASURED VOLUME WAS 29ML. THE PATIENT DOSE WAS DECREASED BY TEN PERCENT AT THAT TIME AND THE RESERVOIR VOLUME WAS UPDATED TO 29ML. ON (B)(6) 2013, THE PATIENT WAS SEEN FOR ANOTHER PUMP CHECK AT WHICH TIME THE EXPECTED VOLUME WAS 26.4 AND THE MEASURED VOLUME WAS 24ML. ON (B)(6) 2013, A CLINIC NOTE PROVIDED INFORMATION RELATED TO THE PATIENT'S CLINICAL COURSE OVER THE LAST SIX MONTHS. THE NOTE STATED THAT THE PATIENT HAD VARIOUS EMERGENCY ROOM VISITS FOR NAUSEA AND FEELING NUMBNESS AROUND HER WAIST. PER PROVIDED CLINIC NOTES, ON (B)(6) 2013, A PUMP REFILL WAS PERFORMED AND THE PLAN WAS TO FOLLOW UP IN 3.5 WEEKS FOR A REFILL. IT WAS NOTED AT THAT TIME "GOOD PAIN RELIEF WITH PUMP WITHOUT SE'S (SIDE EFFECTS)" ON (B)(6) 2013, A PUMP REFILL AND REPROGRAM WERE PERFORMED. THE ASPIRATED AMOUNT FROM THE RESERVOIR WAS LESS THAN EXPECTED BY 8ML; 11.7ML HAD BEEN EXPECTED AND 3.0 ML WAS ASPIRATED AS PREVIOUSLY REPORTED. A ROTOR DYE/CATHETER STUDY WAS ORDERED ASAP. ON (B)(6) 2013, THE ROTOR AND CATHETER DYE STUDY WERE PERFORMED DUE TO "DIZZINESS SUSPICION OF RESERVOIR EMPTYING AT AN ACCELERATED RATE". BOTH WERE NORMAL STUDIES, "NO DISRUPTION". FOLLOWING THE PUMP MYELOGRAPHY THE PATIENT REPORTEDLY COMPLAINED OF SOME NUMBNESS WITHOUT LOSS OF MOTOR FUNCTION WHICH RESOLVED SPONTANEOUSLY. A CT OF THE SPINE WAS ALSO DONE POST THE PUMP MYELOGRAPHY. ALL FINDINGS WERE WITHIN NORMAL LIMITS. IT WAS NOTED UNDER "HISTORY OF PRESENT ILLNESS" THAT THE PATIENT WAS HAPPY WITH PAIN RELIEF. IT WAS ALSO NOTED "VAGUE NUMBNESS MOST LIKELY SECONDARY TO MARCAINE COMPONENT FOR SCIATICA". THE PATIENT WAS REASSURED AND GIVEN A BRIDGE BOLUS. IT WAS ALSO NOTED "NO COMPLICATIONS WERE NOTED". THE PLAN WAS TO FOLLOW UP FOR REFILL BEFORE THE PATIENT'S ALARM WHICH WAS SET FOR (B)(6) 2013. ON (B)(6) 2013, A PUMP REFILL AND REPROGRAM OCCURRED. AT THE REFILL THE EXPECTED VOLUME WAS 7.1ML AND THE ACTUAL VOLUME WAS 6.5ML. NO COMPLICATIONS WERE EVIDENT AT THAT TIME. IT WAS NOTED AT THE VISIT PER NOTES THAT THE LAST TWO REFILLS THE PATIENT'S RESERVOIR VOLUME WAS LESS THAN EXPECTED "7-8ML LIGHT". IT WAS ALSO REPORTED A ROTOR DYE STUDY WAS WITHIN NORMAL LIMITS AND THAT THE PLAN WAS TO BRING THE PATIENT IN TWO WEEKS TO CHECK THE RESERVOIR VOLUME. ON (B)(6) 2013, A PUMP REFILL AND REPROGRAM OCCURRED. 29ML WAS WITHDRAWN WHICH WAS 5.2ML LESS THAN THE 34.2 EXPECTED. THE SIMPLE CONTINUOUS DOSE WAS DECREASED BY 10% AND A NEW ALARM DATE WAS ESTABLISHED. THE PATIENT WAS INSTRUCTED TO RETURN IN ONE WEEK FOR FURTHER EVALUATION IN ORDER TO ACCURATELY CALCULATE THE RATE OF INCREASED MEDICATION LEAVING THE PUMP. IT WAS THEN NOTED PER FURTHER CLINIC NOTES THAT NO REFILL TOOK PLACE ON THE DAY AND THE PLAN WAS TO RECHECK THE VOLUME. IT WAS ALSO WRITTEN "NAUSEA, NUMBNESS X 6 MONTHS". ON (B)(6) 2013, THE PUMP WAS INTERROGATED AND REPROGRAMMED TO AFFECT A CHANGE IN DELIVERED MEDICATION AND A NEW ALARM DATE WAS PROGRAMMED. THE CONCENTRATIONS GOING INTO THE VISIT FOR THE MEDICATIONS WERE DILAUDID AT 6.0MG/ML AND MARCAINE AT 20.0MG/ML. THE ADJUSTMENT WAS CALCULATED TO PROVIDE THE NEEDED PAIN CONTROL FOR INCREASED FUNCTION AND NO COMPLICATIONS WERE NOTED AT THAT TIME. IT WAS NOTED ON THE CLINIC NOTES FOR THE VISIT "RE-EVALUATION ON PUMP FOR SUSPECTED MALFUNCTIONING (GIVING MORE MEDICINE THAN HOW PROGRAMMED). NAUSEA SIDE EFFECTS LESS OVER PAST WEEK, BUT SEDATION STILL PERSISTS. ASPIRATED 24ML AND 26.4 ML WAS EXPECTED. DECREASED SIMPLE CONTINUOUS 10% TODAY. ALARM: (B)(6) 2013. SCHEDULE FOR ASAP PUMP REPLACEMENT".ON (B)(6) 2013 AT A FOLLOW UP VISIT, THE PATIENT'S CHIEF COMPLAINT WAS LISTED AS NAUSEA. PER THE CLINIC NOTES, IT HAD BEEN DETERMINED THAT THE PATIENT'S SYSTEM HAD BEEN MALFUNCTIONING. A COMPLETE WORKUP HAD REPORTEDLY BEEN DONE WHICH SHOWED PATENCY OF THE SYSTEM. IT WAS REPORTED REPEATED ASPIRATIONS PERIODICALLY HAD DEMONSTRATED THAT THE EXPECTED RESIDUAL MARKEDLY OVERESTIMATED WHAT THE ACTUAL RESIDUAL VOLUME WAS. THAT HAD LED TO VARIOUS EMERGENCY ROOM VISITS FOR THE PATIENT DUE TO NAUSEA AND FEELING OF NUMBNESS AROUND HER WAIST. IT WAS REPORTED THIS HAPPENED ON A CONSTANT BASIS AND 'THEY ARE EXTREMELY CONCERNED THAT THE PUMP COULD EVENTUALLY OVER DELIVER THE MEDICATION, LEADING TO AN OVERDOSE. THE PLAN AT THE VISIT WAS TO MAKE ARRANGEMENTS TO DETERMINE THE PROPER COURSE OF ACTION TO TRY TO REPLACE THE PUMP EXPEDITIOUSLY. AT THAT POINT, REDUCTION OF HER DOSE HAD TAKEN PLACE THE PRIOR FRIDAY AND THE PATIENT HAD A "FAIRLY" GOOD WEEKEND. THE HCP OFFERED TO REDUCE THE DOSE BUT THE PATIENT AND HER HUSBAND FELT THAT THE PATIENT HAD BEEN FUNCTIONING WELL AT THE LEVEL SO FAR.
IT WAS REPORTED THAT THE PUMP RESERVOIR SHOWED AN ACTUALLY RESIDUAL VOLUME (ARV) LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV) DURING THE PREVIOUS REFILL AND AT THE PATIENT'S MOST RECENT APPOINTMENT. THE PREVIOUS REFILL HAD A VOLUME DISCREPANCY OF APPROXIMATELY 9-10ML. AT THE PATIENT'S MOST RECENT APPOINTMENT FOR INTERIM CHECK, THE ERV WAS 34.2ML AND THE ARV WAS 29ML. THE PATIENT WAS NOT DUE FOR A REFILL UNTIL (B)(6) 2013. THE PATIENT WAS HAVING SYMPTOMS OF NAUSEA AND VOMITING, SEDATION AND NUMBNESS. THE HEALTHCARE PROVIDER (HCP) QUESTIONED OVERINFUSION BY THE PUMP. THE CALLER WAS TO DISCUSS WITH THE HCP HOW TO DIAGNOSE THE PROBLEM; HOWEVER, THE CALLER WANTED TO EMPTY THE SYSTEM AND RUN A BOLUS AND THEN CHECK THE RESERVOIR VOLUME. THE DEVICE SYSTEM DELIVERED DILAUDID AND MARCAINE. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR FURTHER EVALUATION ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340853 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Required Intervention |