FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1150455
·
Received September 5, 2008
Report
- Report Number
- 2182207-2008-05509
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- January 1, 2007
- Report Date
- August 9, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REMOVED AS IT "WAS NOT PROPERLY CONNECTED". NO OTHER INFO WAS PROVIDED AT THE TIME OF THIS REPORT. ADDITIONAL INFO 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED| PROGRAMMER MODEL 8840| CATHETER MODEL 8709| EXPLANTED |