FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1201521
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06639
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 18, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CATHETER BREAK HAD OCCURRED. THE CATHETER WAS REVISED. NO PATIENT SYMPTOMS OR OUTCOME WERE REPORTED. THE PUMP CONTAINED GABAPENTIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER MDOEL 8709SC LOT# N143751022| PROGRAMMER MODEL 8840 LOT# UNKNOWN |