SYNCHROMED II
Report
- Report Number
- 3007566237-2013-02325
- Event Type
- Injury
- Date Received
- July 12, 2013
- Report Date
- June 19, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-8, LOT# N257966, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
IT WAS LATER REPORTED THAT THE PUMP DOSAGE ¿WASN¿T ABOVE 30% CAPACITY¿ AND THE PATIENT¿S MAIN PROBLEM WITH THE PREVIOUS DOCTOR WAS THAT HE WOULD ONLY INCREMENT THE DOSE IN SMALL AMOUNTS THAT DID NOT HELP. HOWEVER, THE PATIENT ALSO STATED THAT THE PUMP WAS THE BEST THING THAT EVER HAPPENED TO HIM AND THAT HE COULD NOT BE MORE PLEASED; THE PATIENT DID NOT LIKE TAKING ORAL MEDICATION BECAUSE OF THE ROLLER COASTER EFFECT. THE PATIENT RARELY SAW THE PHYSICIAN AND WAS TREATED AND REFILLED BY THE PHYSICIAN ASSISTANT WHO COULD NOT ANSWER THE PATIENT¿S QUESTIONS. THE PATIENT STATED THAT AFTER SIX YEARS WITH THIS DOCTOR HE LOST ALL CONFIDENCE IN HIM A YEAR AGO. THE PATIENT DECIDED TO SEEK ANOTHER PHYSICIAN BUT DID NOT REALIZE HOW DIFFICULT IT WOULD BE TO FIND ANOTHER DOCTOR TO MANAGE THE PUMP. HOWEVER, ANOTHER HOSPITAL THAT THE PATIENT WENT TO TOLD THE PATIENT THAT THEY HAD A DOCTOR WHO MANAGED PUMPS. SINCE THE PUMP RAN EMPTY THE PATIENT WAS UNDER THE CARE OF HIS PRIMARY CARE PHYSICIAN WHO HAD BEEN ¿KEEPING THE PATIENT GOING¿. THE PATIENT STATED THAT HIS BLOOD PRESSURE BECAME WITHIN STROKE RANGE AND WAS 260/150. THE PATIENT MADE 5-6 TRIPS TO THE EMERGENCY ROOM (ER). AFTER THAT THE PRIMARY CARE PHYSICIAN WORKED HARD WITH THE PATIENT TO BRING THE BLOOD PRESSURE CLOSE TO NORMAL RANGE. THE PATIENT STATED THAT HE WAS CLEARED FOR PUMP REPLACEMENT SURGERY ON (B)(6) 2014 AND THAT HE WANTED TO GET A NEW PUMP PLACED AND ¿TUNED UP¿ SO THAT HE COULD GET HIS LIFE BACK. THE PATIENT STATED THAT THERE WERE DAYS THAT HE COULD NOT GET UP AND DO ANYTHING. THE PATIENT WAS CURRENTLY TAKING ONLY ORAL PERCOCET.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CRITICAL PUMP ALARM HAD BEEN SOUNDING EVERY HOUR ON THE HOUR. IT WAS STATED THAT THE PATIENT HAD BEEN GOING THROUGH A ?LIVING HELL" AND HAD HEALTH ISSUES LIKE HYPERTENSION. HE ALSO HAD OTHER HEALTH ISSUES BECAUSE HIS PAIN WAS SO SEVERE; THE PATIENT WAS WORRIED THAT IT WAS GOING TO KILL HIM. IT WAS INDICATED THAT THE PATIENT WAS DIAGNOSED WITH A PULMONARY EMBOLISM AND, ON (B)(6), 2013, WAS PUT ON COUMADIN AND PERCOCET FOUR TIMES A DAY; HOWEVER, THESE ONLY TOOK THE EDGE OFF OF THE CHRONIC PAIN. IT WAS INDICATED THAT THE PUMP COULD NOT BE REPLACED FOR NINE MONTHS BECAUSE OF HIS HEALTH ISSUES. IN ADDITION, IT WAS STATED THAT A NURSE TOLD THE PATIENT THAT HIS PUMP DOSE HAD BEEN AT ONLY 30% OF THE MAXIMUM LEVEL WHEN HE WAS ALSO THINKING HIS INTRATHECAL DOSE WAS NOT HIGH ENOUGH.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAS ONLY BEEN SEEN ONCE BY THE PHYSICIAN BACK ON (B)(6) 2013 FOR A CONSULT. IT WAS REPORTED AT THAT TIME THE LOW, EMPTY RESERVOIRS AND ERI ALARMS HAD BEEN ACTIVATED. ERI HAD OCCURRED ON (B)(6) 2013 WITH AN EOS ON (B)(6) 2013. RESERVOIR VOLUME WAS 0MLS AND 47.7MLS DISPENSED SINCE UPDATE PER THE CLINICIAN PROGRAMMER PUMP STATUS. IT WAS REPORTED HCP DID NOT HAVE ACCESS TO REVIEW THE EVENT LOGS WHEN PATIENT WAS SEEN ON (B)(6) 2013. THE PUMP WAS NOT REPLACED DUE TO INSURANCE ISSUES AND CARDIAC/HEART PROBLEMS. THERE WERE NEVER PUMP ALARMS HEARD AND THEY DID NOT CONFIRM ACTIVE ALARM STATUS ON THE CLINICIAN ALARMS SCREEN. THERE WERE NO RE-INTRODUCTIONS OF IT DRUG DELIVERY AND NO OTHER APPOINTMENTS SCHEDULED FOR THE PATIENT. THE PUMP'S PREVIOUS DRUG RESERVOIR WAS DILAUDID AND BUPIVACAINE.
IT WAS REPORTED THAT THE PUMP HAD BEEN DRY SINCE (B)(6) AND THE PATIENT BEGAN HAVING BLOOD PRESSURE ISSUES THAT RESULTED IN SIX EMERGENCY ROOM VISITS. IT WAS STATED THAT THE PATIENT¿S BLOOD PRESSURE HAD BEEN GETTING INTO THE STROKE ZONE, THOUGH HIS NEW PHYSICIAN GOT IT UNDER CONTROL FOR THE MOST PART. ADDITIONALLY, THE PUMP HAD BEEN DUE TO BE REPLACED IN (B)(6) AND HAD REACHED END-OF-SERVICE. AT THE TIME OF REPORT, THE PATIENT HAD BEEN DISMISSED FROM HIS MANAGING PHYSICIAN¿S CARE AND WAS HAVING TROUBLE LOCATING A NEW MANAGING PHYSICIAN. THE PATIENT WANTED TO HAVE THE PUMP REPLACED AS IT WAS STILL ALARMING AND HE COULDN¿T TOLERATE HIS LEVEL OF PAIN MUCH LONGER. TWO WEEKS LATER, IT WAS REPORTED THAT THE PUMP WAS DUE TO EXPIRE DURING THE MONTH FOLLOWING REPORT. IT WAS STATED THAT THE PUMP WAS PREVIOUSLY FILLED WITH DILAUDID AND GAVE THE PATIENT CONSISTENT RELIEF; HOWEVER, IT WAS NOTED THAT HIS CHRONIC PAIN HAD TAKEN A TOLL ON HIM OVER THE MANY YEARS. IT WAS ALSO STATED THAT THE PATIENT¿S HYPERTENSION WAS CAUSED BY THE INCREASE OF HIS PAIN LEVEL. EVERY TIME HIS PAIN LEVEL WENT UP, HIS BLOOD PRESSURE WOULD GO THROUGH THE ROOF. FIVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT STILL COULD NOT FIND A PHYSICIAN TO REPLACE THE PUMP. IT WAS STATED THAT THE PATIENT WAS NOT SURE HOW MUCH LONGER HIS BODY WAS GOING TO BE ABLE TO WITHSTAND THE STRESS IT HAD BEEN PUT UNDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324474 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |