FDA Adverse Event
Malfunction
Summary report: N
N'VISION
MDR report key: 1041271
·
Received May 9, 2008
Report
- Report Number
- 2182207-2008-02520
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 10, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AT PUMP REPLACEMENT THE DRUG CONCENTRATION WAS CHANGED. IT WAS LATER REALIZED THAT A BRIDGE BOLUS HAD NOT BEEN PROGRAMMED. NO REPROGRAMMING WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | N'VISION | LKK | MEDTRONIC NEUROMODULATION | 8840 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT NGV415774H| EXPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863740| CATHETER MODEL 8703W LOT# L52357| IMPLANTED| CATHETER MODEL 8596SC LOT# N121185031| EXPLANTED| IMPLANTED| EXPLANTED |