SYNCHROMED II
Report
- Report Number
- 3004209178-2013-08540
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 13, 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
(B)(4).
(B)(4).
PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4): IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETURNED SPASTICITY AND HALLUCINATIONS. THE DOSE WAS READJUSTED BY THE PHYSICIAN AND THE PATIENT WAS REPORTED TO BE ¿DOING FINE NOW¿.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PRESENTED A COUPLE DAYS AFTER THE PUMP REPLACEMENT TO THE HEALTH CARE PROVIDER¿S (HCP) OFFICE WITH SYMPTOMS INCLUDING UNDER DOSING, MILD WITHDRAWAL SYMPTOMS AND ITCHING. IT WAS NOTED THE PROGRAMMING ERROR WAS DUE TO HUMAN ERROR AT THE TIME OF THE PUMP REPLACEMENT IN THE OPERATING ROOM. THE PATIENT RECOVERED WITHOUT SEQUELAE.
IT WAS REPORTED THE PATIENT¿S PUMP WAS PROGRAMMED TO 2000 MCG/ML, BUT THE PUMP ACTUALLY HAD 500 MCG/ML IN IT FROM THE DAY IT WAS IMPLANTED. WITHDRAWAL WAS REPORTED, WHICH OCCURRED OVER THE NEXT SEVERAL DAYS AFTER THE PUMP WAS REPLACED. THE PUMP WAS BEING USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THE HEALTHCARE PROVIDER (HCP) PLANNED TO RE-PROGRAM THE PUMP AND INCREASE THE PATIENT¿S DOSE ON THE DATE OF THIS REPORT. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244647 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Other |