SYNCHROMED II
Report
- Report Number
- 3004209178-2014-13245
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- June 26, 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
- KY, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
THE PATIENT WAS QUESTIONING WHAT MEDICATION WAS IN THE PUMP. THE PATIENT STATED THAT THEY GOT A LETTER NOT LONG AGO REGARDING GABAPENTIN AND TORADOL AND THE PATIENT WAS ALLERGIC TO ¿ALL THAT STUFF¿. THE PATIENT HAD BEEN HAVING ALL KINDS OF TROUBLE WITH THIS PUMP GOING ON IN HER HEAD AND STUFF¿. THE PATIENT BELIEVED THE HCP CHANGED OUT THEIR MEDICATION ABOUT 2 MONTHS AGO AND DIDN¿T TELL THE PATIENT. PER THE PATIENT GABAPENTIN OTHERWISE KNOWN AS NEURONTIN MAKES THE PATIENT HAVE SEIZURES, TORADOL GIVES THE PATIENT ¿NERVOUS LEG SYNDROME¿ AND THE PATIENT COULDN¿T THINK OF THE THIRD MEDICATION. THE PATIENT STATED THAT THEY HAD TAKEN HER ¿ZANTEC¿ BEFORE THEIR LAST APPOINTMENT AND THE PATIENT WAS A LITTLE DROWSY. 4 MONTHS AGO THE PATIENT WAS FINE. THE PATIENT HAS HAD THE PUMP FOR 2 YEARS AND HAD NEVER HAD THIS PROBLEM. THE PATIENT¿S LAST REFILL AS ALSO 4 MONTHS AGO. OVER THE LAST COUPLE OF MONTHS THE PATIENT HAD BEEN HAVING PROBLEMS WITH SEIZURES AND STATES THEY JUST HAD ONE THAT LASTED 3 DAYS AND THE PATIENT JUST CAME OUT OF IT YESTERDAY, THE DAY BEFORE THE REPORT. PER THE PATIENT THEY HAD BEEN SO ¿OUT OF IT¿ THE PATIENT TRIED TO GO OUTSIDE IN THEIR UNDERWEAR AND HAD BEEN CARRYING DIRTY CLOTHES AROUND. THE PATIENT FEELS THERE IS SOMETHING WRONG WITH THE MEDICATION THE PATIENT HAD IN THE PUMP. THE PATIENT STATED THEY HAD BEEN YELLING AT THEIR FAMILY AND DOING REALLY ¿WEIRD¿ THINGS. THE PATIENT HAD NOT BEEN USING HER ¿BOOST¿ AND THE DAY OF THE REPORT THEY WERE ¿NORMAL¿ AND STATED ¿SOMETHING IS WRONG.¿ PER THE PATIENT THEY ARE SUPPOSED TO HAVE MORPHINE AND STATED THE DOSE WAS 14MCG, THEN STATED IT WAS 13MCG AND WITH THE ¿BOOST¿ WAS UP TO 19MCG. THE PATIENT WAS NOT EXACTLY SURE AND DID NOT KNOW THE CONCENTRATION, OR WHAT CURRENTLY WAS IN THE PUMP, THE PATIENT GOES IN FOR A ¿FILLUP¿ ON THE 8TH. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
ON (B)(4) 2014 INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT¿S DOSE WAS UP TO 20 (UNITS NOT PROVIDED) AND THEY DID NOT KNOW IT. THEY NOTICED THAT ANYTIME THEY CLOSED HER EYES ¿SHE WOULD BE OUT¿. THERE WERE THINGS THEY COULD NOT DO BEFORE THAT THEY NOW COULD. THEIR PHYSICIAN TOLD THE PATIENT TO MAKE AN APPOINTMENT. THE PHYSICIAN WANTED TO LOWER THE PUMP DOSE, ¿DRY IT UP¿, AND LEAVE THE PUMP IMPLANTED FOR SIX MONTHS IN CASE THEY NEEDED IT. THE PATIENT STATED THAT ¿THEY DROPPED HER 6 MG.¿ THEY TOLD THE NURSE THAT THEY COULD NOT GO THAT HIGH ANYMORE BECAUSE THINGS HAPPENED THAT THEY HAD NEVER SEEN BEFORE. THE NURSE TOLD THE PATIENT THAT THEY LOOKED AT THE DOCTOR AND SAID ¿WHAT HAVE WE DONE¿. THEY APOLOGIZED AS THEY HAD NEVER ¿DROPPED ANYBODY THAT MUCH.¿ THE PATIENT WAS LOOKING FOR A PHYSICIAN THAT COULD REMOVE THE PUMP IN MICHIGAN.
IT WAS LATER REPORTED THAT THE PATIENT HAD A HEALTHCARE PROVIDER (HCP) THAT SAID HE WOULD REMOVE HER DEVICE WHEN HE GOT ALL OF THE PATIENT¿S INFORMATION. THE CAUSE OF THE EVENT, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422700 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | Other| R |