FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2853860
·
Received December 3, 2012
Report
- Report Number
- 3004209178-2012-11041
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8780, LOT# 0205986041, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6). (B)(4).
Description of Event or Problem · 1
A POCKET INFECTION WAS REPORTED. PATIENT WAS HOSPITALIZED. IT WAS STATED THAT PATIENT HAD A SEROMA; "HOT, RED POCKET WITH WOUND LIQUID". BLOOD PARAMETERS FOR INFECTION WERE HIGH. LOCATION WAS THE DEVICE POCKET AND CATHETER TRACK. DRUGS DELIVERED VIA THE DEVICE WERE MORPHINE AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Hospitalization| R |