SYNCHROMED II
Report
- Report Number
- 3004209178-2014-08090
- Event Type
- Injury
- Date Received
- April 24, 2014
- Date of Event
- March 24, 2014
- Report Date
- April 4, 2014
- 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
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8 590-1, LOT # N185021, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8835, SERIAL# PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED A MOTOR STALL OCCURRED WITH UNKNOWN RECOVERY. THE PTM SHOWED AN 8476 ERROR CODE. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF AND WENT TO THE EMERGENCY ROOM (ER) WITH LACK OF PAIN CONTROL. THE PATIENT WAS BEING MANAGED AND THE HEALTH CARE PROVIDER (HCP) TURNED THE PUMP TO MINIMUM RATE. THE LOGS WERE CHECKED. THE PRODUCT ISSUE WAS NOT RESOLVED AND THE CAUSE WAS NOT DETERMINED. THE DRUG IN THE PUMP WAS THOUGHT TO BE FENTANYL. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ IT WAS LATER REPORTED THE PATIENT HAD INCREASED PAIN AND THE PUMP WAS ALARMING DUE TO AN 8476 ERROR CODE. THE ERROR CODE WAS SEEN THE NIGHT PRIOR TO THE DATE OF THIS REPORT. IT WAS FURTHER REPORTED THE PUMP CONTAINED FENTANYL. IT WAS BELIEVED THE DOSE WAS INCREASED FROM 1 MICROGRAM TO ¿1. SOMETHING MG¿ FOR THE DOSE. THE PREVIOUS NIGHT WHEN THE PATIENT TRIED TO GET A BOLUS, HE WAS UNABLE TO BECAUSE OF THE ERROR CODE. THE CODE WAS STILL PRESENT. THE PUMP ALARMED 5 TIMES AND THE PATIENT¿S PAIN WAS ¿OFF THE CHARTS.¿ THERE WAS AN MRI ABOUT A MONTH AND A HALF OR TWO MONTHS AGO. THE PATIENT DID NOT HAVE MEDICAL TESTING THE DATE OF THE REPORT AND PRIOR TO THE NIGHT BEFORE THE BOLUSES DELIVERED FINE. IT WAS FURTHER REPORTED TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING DUE TO MOTOR STALL. THE STALL WAS INTERMITTENT BUT THE PUMP HAD BEEN STALLED SINCE THE DAY PRIOR TO THE DATE OF THIS REPORT. THERE WERE PREVIOUS STALLS AND RESTARTS GOING BACK TO (B)(6) 2014. THE PATIENT HAD WITHDRAWAL-TYPE SYMPTOMS OF NAUSEA, VOMITING, AND THE PATIENT COULD NOT HOLD STILL. THE SYMPTOMS STARTED LAST NIGHT. THE PATIENT HAD BEEN HAVING OTHER ¿PROBLEMS¿ BUT IT WAS NOT CLEAR WHAT THOSE WERE. IT WAS REPORTED THE PATIENT HAD ISSUES WITH THE PERSONAL THERAPY MANAGER (PTM) SINCE THE DAY THE PATIENT STARTED TO UTILIZE IT 2.5 MONTHS AGO. THE PATIENT CALLED INTO THE CLINIC 4-6 TIMES PER WEEK WITH ISSUES. THE PATIENT WAS IN THE ER AT THE TIME OF THE REPORT WITH THE VISIT BEING THE PATIENT¿S SECOND. THE PTM WAS MALFUNCTIONING AND THE PATIENT HAD WITHDRAWAL FOR THE PAST 2-3 DAYS. IT WAS REPORTED THE PATIENT WAS GOING TO DETOX AND ON THEIR WAY TO THE EMERGENCY ROOM FOR CHEST PAIN. THE HCP TRIED BUT WAS UNABLE TO PROGRAM THE PUMP TO MINIMUM RATE MODE. AFTER TROUBLESHOOTING, THE PUMP WAS SUCCESSFULLY PROGRAMMED TO MINIMUM RATE MODE. THE PATIENT WAS IN WITHDRAWAL BECAUSE ¿THE PUMPS DON¿T WORK.¿ FIVE DAYS LATER IT WAS REPORTED THE STALL DID NOT RECOVER TO THE REPORTER¿S KNOWLEDGE AND THE CAUSE OF THE STALL WAS NOT DETERMINED. NO REPLACEMENT WAS SCHEDULED. THE PATIENT WAS BEING MEDICALLY COVERED BY HIS HCP. IT WAS ALSO REPORTED THAT ¿IN HINDSIGHT¿ THE PATIENT COULD SEE THE PUMP HAD STUTTERED MANY TIMES. THE PATIENT WAS SEEING A SURGEON TO SEE FI THE FAILED PUMP WAS GOING TO BE REPLACED. THE PUMP WAS NOT DUE FOR REPLACEMENT FOR 18 MONTHS. AFTER THE PATIENT WOULD ¿LEAVE THE SERVICE¿ THE PAIN WENT ¿OFF THE CHART¿ AND HIS LEGS STARTED FAILING AND KNEES STARTED BUCKLING. THE PATIENT¿S LEGS, ARMS, AND WHOLE BODY FELT LIKE IT WAS BEING ON FIRE BURNING ¿NOT GOOD¿ NEUROPATHY. IT WAS LATER REPORTED THE PATIENT¿S BODY FELT LIKE HE WAS PERCOLATING IN BOILING PURE ACID IN EVERY CELL. THE PUMP HAD STALLED BEFORE BUT ALWAYS STARTED UP AGAIN. THE PUMP WAS DEAD-FAILED. THE PATIENT HAD SHOCK FROM NOT GETTING A CONSTANT DOSE OF MEDICATION FROM 2009. HIS LOW BACK WAS IN CONSTANT PAIN AND 10 VERTEBRAE BEING CRUSHED AND ALL DISCS BEING BULGED. THE PATIENT MADE IT TO THE HOSPITAL AND WENT INTO ¿FULL DT¿S.¿ THE PATIENT¿S ABS WERE FOL DING UP LIKE AN ACCORDION. EVERY 3 MINUTES THE PATIENT HAD VIOLENT DRY HEAVES LASTING FOR 3 MINUTES. IT CAUSED PAIN IN THE PATIENT¿S HEART. IT WAS NOTED THAT PAIN COVERAGE WAS ONLY 10% OF WHAT THE PUMP COVERED. IT WAS LATER REPORTED THE PATIENT WAS PUT ON ORAL MEDICATION. THE PATIENT HAD 3 SURGERIES ON L5 TO S1 BEFORE THE PUMP THERAPY. THE ¿10 VERTEBRAE SMASHED¿ ALSO OCCURRED BEFORE PUMP THERAPY. THE PATIENT ALSO HAD FIBROMYALGIA, RHEUMATOID ARTHRITIS, AND OSTEOARTHRITIS WHICH CAUSED PAIN. THE PATIENT¿S EYES WERE ¿MESSED UP¿ BECAUSE THE PUMP WAS OFF. HE COULD NOT FOCUS AND HIS MIND WAS NOT VERY CLEAR. THE PATIENT HAD STOMACH CRAMPING AND SWEATING. THE PAIN WAS IN THE PATIENT¿S FEET, HANDS, AND ¿BASICALLY EVERYWHERE.¿ IT WAS NOTED THE PUMP HAD ONLY LASTED 18 MONTHS, BUT THIS WAS UNCONFIRMED AS RECORDS SHOWED THE PUMP WAS IMPLANTED (B)(6) 2009.
IT WAS LATER REPORTED THAT THE PATIENT PRESENTED TO THE HEALTHCARE PROVIDER'S (HCP) CLINIC "IN TOTAL MISERY." IT WAS NOTED THAT THE PATIENT DID NOT HAVE AN APPOINTMENT, SO THIS VISIT WAS EMERGENT. THE PATIENT COULDN'T CONTROL HIS PAIN AND WAS ROLLING OUT OF BED. ONCE THE PATIENT GOT SETTLED IN, HE STARTED HAVING CHEST PAIN AND THE HCP HAD TO CALL AN AMBULANCE. THE PATIENT ALSO EXPERIENCED VOMITING AND SWEATING. IT WAS NOTED THAT THE PATIENT HAD PUMP REFILLS EVERY 3 TO 3.5 WEEKS. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL.
IT WAS REPORTED THAT THERE WAS A PROBLEM WHERE THE PERSONAL THERAPY MANAGER (PTM) WAS NOT SAYING THE SAME DAILY DOSE AS WHAT THE PUMP WAS SUPPOSED TO BE. IT WAS FURTHER STATED THE PROBLEM WAS THE REFILL SLIP SAID ONE THING AND THE PTM SAID ANOTHER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ¿GETTING COVERED IN RASHES,¿ THEIR LEGS ¿BUCKLE¿ AND THEY HAD TO STAY HOME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MOTOR STALL HAD NOT RECOVERED SINCE (B)(6) 2014 AT 12:58. TUBE SET HAD OCCURRED ON (B)(6) 2014 AT 12:58. IT WAS NOTED THAT THE PUMP WAS ALARMING AND HAD BEEN 4-5 TIMES A DAY FOR ¿1+ YEARS.¿ EVENT LOGS CONFIRMED ALARM ACTIVATION. THERE WAS A MOTOR STALL RECOVERY SEEN ON (B)(6) 2014 AT 22:20 BUT THE LOGS DID NOT GO BACK FAR ENOUGH TO CONFIRM WHEN THE STALL HAD OCCURRED. THE PUMP WAS PROGRAMMED TO MINIMUM RATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN ON A VERY HIGH DOSE OF MEDICATION WHICH WAS NOT APPROVED FOR USE WITH THE PUMP. IT WAS NOTED THAT THE PATIENT COULD NOT FIGURE OUT WHY THEY WERE USING THEIR PTM EVERY COUPLE HOUR OR SO AND WERE EXPERIENCING BREAKTHROUGH PAIN SO OFTEN. IT WAS NOTED THAT THE LOGS WERE PRINTED FOR THE PATIENT AND AFTER EXPLAINING TO THE PATIENT WHY THEY WERE GETTING LOCKED OUT; PATIENT UNDERSTOOD. PATIENT LOGS SHOWED A BOLUS DENIED FOR LOCKOUT INTERVAL ¿89¿ THAT CORRESPONDED TO A SUCCESSFUL PA REQUEST INDICATED BY AN ¿88¿ ON 2 (B)(6) 2014 (X2), (B)(6) 2014 (X2), (B)(6) 2014 (X3). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN HAVING ¿OFF AGAIN, ON AGAIN¿ PUMP ISSUES FOR ABOUT 1.5 YEARS. IT WAS NOTED THAT THE PTM 24 HOUR LOCK OUT ISSUE HAD BEEN RESOLVED. IT WAS UNKNOWN IF A REPLACEMENT SURGERY WAS SCHEDULED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AS OF (B)(6) 2014 THE PATIENT HAD NOT BEEN SCHEDULED FOR REPLACEMENT. THE SYMPTOMS POST MOTOR STALL WAS COVERED BY ORAL MEDICATION PER THE MANUFACTURE REPRESENTATIVES UNDERSTANDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250243 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Required Intervention |