FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1201520
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06636
- 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 THERE WAS A CATHETER LEAK NOTED ON X-RAY. DURING REVISION SURGERY, THE CATHETER WAS FOUND TO BE BROKEN. 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 | EXPLANTED:| CATHETER MODEL 8709SC LOT# N111022007| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN |