FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202665
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-04612
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 9, 2012
- Report Date
- June 11, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
A PROBLEM WAS REPORTED. COMPANY REPRESENTATIVE REPORTED PATIENT HAD A PUMP IMPLANTED TWO DAYS AGO AND IT WAS FILLED WITH 5 MG/ML MORPHINE. THE HCP WAS NOT SURE IF THE PUMP WAS FILLED WITH 5 MG/ML OR 0.5 MG/ML. HCP WAS PLANNING ON REFILLING THE PUMP WITH 5 MG/ML CONCENTRATION. NO PATIENT SYMPTOMS OR OUTCOME WERE REPORTED. LATER HCP REPORTED PATIENT NOT BEEN SEEN BY DR. (B)(6) SINCE (B)(6). INDICATED PATIENT BEEN SEEN BY DR. (B)(6). THE SYSTEM WAS USED TO DELIVER MORPHINE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302809 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR |