FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1242956
·
Received November 21, 2008
Report
- Report Number
- 2182207-2008-07643
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 27, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD NOT EXPERIENCED THERAPEUTIC EFFECT; SPECIFICALLY, INCREASED PAIN. THE CATHETER WAS FOUND TO BE KINKED. THE PATIENT WAS UNDERGOING CATHETER REVISION ON THE DAY OF THIS REPORT. 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 | 50 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL 8711| PROGRAMMER: MODEL 8840 |