FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1083473
·
Received July 29, 2008
Report
- Report Number
- 2182207-2008-04465
- Event Type
- Injury
- Date Received
- July 29, 2008
- Date of Event
- January 1, 2006
- Report Date
- July 1, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REMOVED DUE TO A STAPH INFECTION. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8703W LOT# L35841| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN |