FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3203085
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-00662
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- June 28, 2011
- Report Date
- January 16, 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
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE PUMP ¿CAUSED CONSIDERABLE PROBLEMS SINCE IT WAS FIRST IMPLANTED¿. NO SPECIFIC ALLEGATIONS REGARDING PUMP PERFORMANCE WERE REPORTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HALLUCINATIONS AND LEG SWELLING. AT THE TIME OF THIS REPORT, THE PATIENT REQUESTED THAT THE PUMP BE EXPLANTED. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301251 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR |