FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 1213770
·
Received October 22, 2008
Report
- Report Number
- 2182207-2008-06752
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- September 25, 2008
- Report Date
- September 26, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
DURING SURGERY, THE PHYSICIAN NOTICED THE CATHETER WAS LEAKING. THE CATHETER WAS IMMEDIATELY EXPLANTED AND REPLACED. THERE WAS NO PT INJURY. FOLLOWING THE SURGERY, THE PT HAD A GOOD THERAPY OUTCOME.
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 | IMPLANTED:| CATHETER: MODEL 8709SC| EXPLANTED: |