FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1253167
·
Received December 5, 2008
Report
- Report Number
- 2182207-2008-08038
- Event Type
- Injury
- Date Received
- December 5, 2008
- Report Date
- November 11, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT REOPERATION, DUE TO BACLOFEN PUMP CATHETER DISCONNECTION PROBLEMS. THE CATHETER WAS BROKEN OFF AT THE LUMBAR SIDE. NO PT SYMPTOMS WERE REPORTED. THE HCP INDICATED THAT THE INTRADURAL PORTION OF THE CATHETER WAS VERY THIN AND FRAGILE. NO OTHER INFO WAS PROVIDED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL CATHETER| EXPLANTED:| IMPLANTED: |