SYNCHROMED II
Report
- Report Number
- 3004209178-2017-05073
- Event Type
- Injury
- Date Received
- March 6, 2017
- Date of Event
- May 7, 2010
- Report Date
- April 27, 2017
- 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8731SC LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID 8709SC LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID 8590-1 LOT# N242817 SERIAL# IMPLANTED: (B)(6) 2010 EXPLANTED: PRODUCT TYPE ACCESSORY PRODUCT ID 8835 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED IN CLARIFICATION OF THE PRE-OP AND POST-OP DIAGNOSIS BEING LISTED AS ¿PUMP FAILURE¿ THE HEALTHCARE CARE PROVIDER INDICATED THE PUMP WAS ALARMING (B)(6) 2017 AND CAME TO THE OFFICE. WHEN ASKED IF THE CAUSE FOR BEING UNABLE TO ASPIRATE CSF (CEREBRAL SPINAL FLUID) DURING THE PUMP REPLACEMENT DETERMINED THE HEALTHCARE PROVIDER STATED THAT ASPIRATION OF CSF (CEREBRAL SPINAL FLUID) IS NOT ALWAYS POSSIBLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING FENTANYL (2000 MCG/ML AT 849.6 MCG/DAY), BUPIVACAINE (20 MG/ML AT 8.496 MG/DAY) AND CLONIDINE (400 MCG/ML AT 169.93 MCG/DAY). THE INDICATION FOR PUMP USE WAS FAILED BACK SURGERY SYNDROME AND NON-MALIGNANT PAIN. ON (B)(6) 2017 THE PATIENT REPORTED THAT THE PUMP STARTED BEEPING A COUPLE OF DAYS AGO, BUT THEN ALSO REPORTED THAT IT HAD BEEN BEEPING FOR 24 HOURS. SHE COULDN¿T GET HELP FROM HER PHYSICIAN BECAUSE THE PHYSICIAN WAS CURRENTLY ON LEAVE. THE PUMP WAS DUE FOR REPLACEMENT; IT WAS NEAR EXPECTED ERI (ELECTIVE REPLACEMENT INDICATOR). YESTERDAY, THE PATIENT NOTICED A CODE ON HER PTM (PERSONAL THERAPY MANAGER) THAT STARTED WITH AN ¿8 MAYBE 8335 OR 8835¿. THE PATIENT HAD NO SYMPTOMS. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE ON (B)(6) 2017 AND IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT ON (B)(6) 2017. AN ALARM WAS HEARD ON THE DAY PRIOR TO THIS REPORT DATE BUT TELEMETRY HAD NOT YET BEEN PERFORMED DUE TO LACK OF CLINICIAN PROGRAMMER (8840). NO SYMPTOMS WERE REPORTED. THE COMPANY REPRESENTATIVE WAS GOING TO TALK WITH THE DOCTOR ABOUT GETTING THE PUMP INTERROGATED OR HAVING THE PATIENT CHECK THE PUMP WITH THE PERSONAL THERAPY MANAGER (PTM) TO TRY TO GET THE CURRENT ALARM CODE. IT WAS NOTED THAT AT THE LAST REFILL, THE SESSION REPORT SAID ELECTIVE REPLACEMENT INDICATOR (ERI) OF LESS THAN ONE MONTH, THE COMPANY REPRESENTATIVE BELIEVED THAT THE PUMP STARTED ALARMING ON THE DAY PRIOR TO THIS EVENT REPORT DATE. THE TECHNICAL SERVICE SPECIALIST DISCUSSED THAT IT COULD BE THE ERI ALARM SOUNDING, BUT THAT THE PUMP WOULD NEED TO BE CHECKED TO BE CERTAIN. ON (B)(6) 2017 ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA CLINIC NOTES. THE PATIENT¿S MEDICAL HISTORY INCLUDED MULTIPLE PAIN ISSUES, CHRONIC PAIN IN MULTIPLE AREAS, FAMILIAR ADENOMATOUS POLYPOSIS COLI, MULTIPLE RECURRENT DESMOID TUMORS, A TOTAL COLECTOMY AND J-POUCH RECONSTRUCTION, SURGICAL RESECTION OF TUMORS, RADIATION THERAPY OF TUMORS, NECK SURGERY, CHEMOTHERAPY, AND A BOWEL OBSTRUCTION. IT WAS NOTED THAT THE PUMP HAD BEEN HELPING WITH THE PATIENT¿S LOWER BACK PAIN, BUT SHE CONTINUED TO HAVE SIGNIFICANT PAIN IN THE NECK AREA. THE NECK PAIN HAD NOT RESPONDED TO THE USE OF MEDICATIONS AND THE INTRATHECAL PUMP. ON AN UNKNOWN DATE AFTER (B)(6) 2014, THE PATIENT HAD RETURNED TO THE CLINIC WITH A SIGNIFICANT INCREASE IN SYMPTOMOLOGY. IT APPEARED THAT HER TUMOR HAD BEEN INCREASING IN SIZE. THE PAIN APPEARED TO BE EXTENDING FROM THE MID BACK INTO THE LOWER BACK ON THE RIGHT SIDE AND INTO THE RIGHT ABDOMEN. SHE WAS UNABLE TO STAND FOR LONG PERIOD AND SHE FELT SIGNIFICANT TIGHTNESS. SHE ALSO REPORTED SHE HAD BEEN HAVING DIFFICULTY WITH STANDING. SHE REPORTED AN INCREASING AMOUNT OF NUMBNESS ALONG THE ANTERIOR THIGH ON THE RIGHT SIDE. THIS WAS RELATED TO COMPRESSION OF THE NERVES. ON (B)(6) 2015, THE PATIENT WAS SEEN FOR A REGULAR PUMP REFILL VISIT. SHE REPORTED SHE HAD LOST MORE WEIGHT AND HAD BEEN FEELING A LOT BETTER. SHE HAD BEEN HAVING A LOT OF PAIN IN THE NECK AND ASSOCIATED HEADACHES. SHE HAD BEEN TAKING HER PRESCRIPTION MEDICATIONS MINIMALLY. ON (B)(6) 2015, THE PATIENT CAME IN FOR A REGULAR PUMP REFILL VISIT. SHE REPORTED THAT SHE HAD BEEN DOING REASONABLY WELL. SHE HAD BEEN HAVING AN INCREASING AMOUNT OF BACK PAIN. SHE HAD BEEN SLEEPING WELL AND HAD APPEARED TO HAVE LOST MORE WEIGHT. SHE LOOKED TIRED. ON (B)(6) 2015, THE PATIENT CAME IN FOR A REGULAR PUMP REFILL VISIT. SHE REPORTED THAT SHE WAS DOING A LOT BETTER. SHE HAD BEEN MORE ACTIVE. HER PAIN CONTROL HAD BEEN QUITE SATISFACTORY. SHE HAD CONTINUED TO HAVE SOME MUSCLE SPASMS AND HAD BEEN DEALING WITH THE SAME. SHE HAD BEEN USING THE PTM (PERSONAL THERAPY MANAGER) WHICH HAD BEEN FAIRLY EFFECTIVE. ON (B)(6) 2015, THE PATIENT CAME IN FOR A REGULAR REFILL VISIT. SHE HAD BEEN HAVING A LOT OF PROBLEMS WITH HER TEETH. SHE CONTINUED TO BE ON TOPAMAX 50 MG TWICE DAILY. SHE HAD ALSO BEEN TAKING FIORICET BECAUSE OF HEADACHES. THEY APPEARED TO BE NOT VERY BENEFICIAL. SHE WOULD LIKELY SEE A DENTIST AND MAY REQUIRE SOME TEETH EXTRACTION. ON (B)(6) 2016, THE PATIENT CAME IN FOR A REGULAR PUMP REFILL VISIT. SHE REPORTED THAT THERE APPEARED TO HAVE BEEN METASTASIS OF TUMOR INTO THE UPPER JAW ON THE LEFT SIDE. SHE WAS SCHEDULED TO MEET WITH AN ORAL SURGEON ON THURSDAY FOR EXTRACTION OF THE TUMOR AND TWO T TEETH. SHE APPEARED TO HAVE LOST SOME WEIGHT. ON (B)(6) 2016, THE PATIENT CAME IN FOR A PUMP REFILL VISIT AND REPORTED THAT SHE HAD BEEN QUITE STABLE. HER PAIN HAD BEEN REASONABLY WELL CONTROLLED. SHE WAS CONCERNED ABOUT POSSIBLE METASTASIS IN HER JAW. ON (B)(6) 2016, THE PATIENT CAME IN FOR A REGULAR PUMP REFILL AND REPORTED THAT SHE HAD BEEN QUITE STABLE. SHE HAD BEEN HAVING SOME PROBLEMS WITH THE HARDWARE ON HER LOWER AND UPPER BACK. SHE WAS SCHEDULED FOR SURGERY CONSULTATION IN A FEW DAYS TIME. IT WAS LIKELY THAT SHE WOULD REQUIRE MORE SPINE SURGERY. SHE ALSO REPORTED THAT THERE APPEARED TO BE INCREASING METASTASIS FROM A DISEASE. ON (B)(6) 2016 THE PATIENT CAME IN FOR A REGULAR REFILL VISIT. SHE HAD BEEN EVALUATED BY A NEUROSURGEON AND IT WAS POSSIBLE THAT HE MAY BE ABLE TO INTERVENE AND HELP WITH ALL THE ISSUE RELATED TO HER BACK. THE PATIENT WOULD REQUIRE MULTIPLE SURGICAL PROCEDURES AND IT WOULD BE QUITE AN EXTENSIVE SURGERY. HE WAS QUITE CONCERNED ABOUT THE STATUS OF HER DISEASE. THE PATIENT WAS QUITE UPSET ABOUT THE WHOLE SITUATION. SHE HAD A BREACH IN THE SKIN RELATED TO ROD SHE HAD IN PLACE. ON (B)(6) 2016, THE PATIENT CAME INTO THE OFFICE URGENTLY AND REPORTED THAT SHE HAD NOT BEEN DOING WELL. SHE HAD BEEN HAVING AN INCREASING AMOUNT OF PAIN. HER PRESCRIPTION PAIN MEDICATION HAD NOT BEEN ADEQUATE. SHE WAS SCHEDULED FOR A BIOPSY AND COLONOSCOPY SOON AND THE SPINAL SURGEON SOMETIME NEXT MONTH. SHE HAD BEEN USING EXTRA PAIN MEDICATIONS. THEY APPEARED TO BE NOT ADEQUATE TO CONTROL HER PAIN. SHE HAD BEEN USING NON-STEROIDAL MELOXICAM AND THIS HAD BEEN UPSETTING HER STOMACH. ON (B)(6) 2016, THE PATIENT CAME INTO THE OFFICE FOR A REFILL VISIT. SHE WAS SCHEDULED FOR MAJOR SPINAL SURGERY ON (B)(6) 2016 AND SHE HAD BEEN STARTED ON CHEMOTHERAPY. SHE HAD LOST ABOUT 15 POUNDS IN WEIGHT AND IT HAD NOT BEEN INTENTIONAL. SHE HAD A DECREASE IN APPETITE. THE USE OF MOVANTIK HAD BEEN EXTREMELY BENEFICIAL WITH REGARDS TO BOWEL MOVEMENTS. ON (B)(6) 2016, THE PATIENT WAS IN THE OFFICE FOR A REGULAR PUMP REFILL AND REPORTED THAT SHE WAS SCHEDULED FOR SURGERY ON (B)(6) 2016. THEY WERE LIKELY TO DO PART OF THE SPINAL SURGERY THEN AND THE SECOND PART IN (B)(6) 2017. THE PATIENT WAS QUITE ANXIOUS ABOUT THE SITUATION. ON (B)(6) 2017 THE PATIENT WAS IN THE OFFICE FOR A REGULAR REFILL VISIT. SHE HAD RECENTLY UNDERGONE SPINAL SURGERY AND THE WOUND WAS HEALED WELL. SHE DID INDICATE THAT THE PRESCRIPTION PAIN MEDICATION GIVEN APPEARED NOT TO BE ADEQUATE AND SHE HAD BEEN FEELING A LITTLE SLEEPY BECAUSE OF THE MEDICATIONS. HER PAIN SCALE WAS 9-10 WITH ACTIVITY. THE IMPRESSION FROM THE VISIT WAS THAT THE PHYSICIAN WAS SATISFIED WITH THE CURRENT PAIN MANAGEMENT. IT APPEARED THAT THE COMBINATION OF MEDICATION S WAS WORKING OUT VERY WELL FOR THE PATIENT. THE PATIENT WAS TOLD SHE NEEDED TO STAY ACTIVE AND EXERCISE ON A REGULAR BASIS. THE IMPORTANCE OF GOOD POSTURE AND WEIGHT CONTROL WAS EXPLAINED. IT WAS REVIEWED THAT THE PUMP HAD LESS THAN ONE MONTH TO ERI (ELECTIVE REPLACEMENT INDICATOR) AND PUMP REPLACEMENT WOULD BE NEEDED. THE PUMP LOGS EXAMINED ON (B)(6) 2016 HAD INDICATED THAT THE PUMP ESTIMATED ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 2 MONTHS. THE PATIENT INDICATED THAT THE PAIN RELIEF WITH THE PRESENT MEDICATION HAD NOT BEEN ADEQUATE. SHE APPEARED TO BE HAVING PAIN IN HER NECK AND LOWER BACK. CHANGING THE PUMP MEDICATION WAS DISCUSSED. THE PATIENT WAS SEEN ON (B)(6) 0217 AND REPORTED THAT HER INTRATHECAL PUMP HAD BEEN RUNNING/ALARMING AND THAT THIS PROBLEM HAD BEEN GOING ON FOR ABOUT A FEW DAYS. THE PATIENT WAS QUITE CONCERNED ABOUT THE SITUATION. SHE INDICATED THAT SHE HAD BEEN USING THE PTM AND IT APPEARED TO BE WORKING FOR HER. HER PAIN SCALE WITH ACTIVITY WAS 7-10. TELEMETRY WAS PERFORMED AND INDICATED THAT ERI HAD OCCURRED. THE PHYSICIAN EXPLAINED TO THE PATIENT THAT ¿THE LOW DOES INDICATE THAT THE PUMP IS WORKING WELL¿. THE PATIENT WAS CLEARED FOR THE PUMP REPLACEMENT PROCEDURE AND IT WOULD BE SCHEDULED. THE PATIENT INDICATED THAT THE PAIN RELIEF WITH THE PRESENT MEDICATION HAD NOT BEEN ADEQUATE. SHE APPEARED TO BE HAVING PAIN IN HER NECK AND LOWER BACK. CHANGING THE PUMP MEDICATION WAS DISCUSSED. ON (B)(6) -2017 THE PATIENT WAS TAKEN TO SURGERY FOR THE PUMP REPLACEMENT PROCEDURE. THE PRE-OP AND POST-OP DIAGNOSES WERE LISTED AS ¿POST-LAMINECTOMY PAIN SYNDROME WITH PUMP FAILURE¿. THE PUMP POCKET WAS OPENED AND THERE WAS A DACRON POUCH AROUND THE PUMP. THE SURGEON WAS ABLE TO DISSECT PART OF THE MESH. THE PUMP WAS DISCONNECTED FROM THE CATHETER. ASPIRATION WAS DONE USING A 1 ML SYRINGE AND THEY WERE NOT ABLE TO GET CSF (CEREBROSPINAL FLUID) IN THE SYRINGE. THE NEW PUMP WAS EMPTIED OF WATER AND REFILLED WITH DRUG. THE CATHETER WAS CONNECTED TO THE PUMP. THE PUMP WAS THEN TETHERED TO THE CAVITY, LOWERED INTO THE CAVITY, AND SECURED. THE AREA WAS IRRIGATED AND THE INCISION WAS CLOSED. THE NEW PUMP AND PTM WERE PROGRAMMED. THE PATIENT TOLERATED THE PROCEDURE FAIRLY WELL AND WAS SENT TO RECOVERY IN A SATISFACTORY CONDITION. SHE WAS INSTRUCTED TO LET THEM KNOW HOW SHE WAS DOING IN A FEW DAYS TIME AND MAKE AN APPOINTMENT TO BE SEEN IN THE OFFICE IN ABOUT 10 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165353 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |