FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2904189
·
Received January 9, 2013
Report
- Report Number
- 3004209178-2013-00352
- Event Type
- Injury
- Date Received
- January 9, 2013
- Report Date
- December 14, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT PROGRAMMER MODE: 8835, SERIAL # (B)(4), CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNKNOWN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS FLUID BUILD-UP AROUND THE PUMP. THERE WAS A REVISION/EXPLORATION SCHEDULED ON (B)(6) 2012. THE PLAN WAS TO MAKE AN INCISION IN THE BACK TO SEE IF THE CATHETER WAS PATIENT AND THEN "POSSIBLY" OPEN THE PUMP POCKET. IT WAS LATER REPORTED THAT THE DOCTOR "TOOK A CLOSER LOOK" AND FOUND THAT IT WAS "ONLY FAT." THE PUMP WAS INFUSING MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12678 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |