FDA Adverse Event
Malfunction
Summary report: N
N'VISION
MDR report key: 1032915
·
Received April 23, 2008
Report
- Report Number
- 2182207-2008-02159
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A BRIDGE BOLUS WAS NOT PERFORMED AT A REFILL VISIT WHEN THE LIORESAL CONCENTRATION WAS INCREASED FROM 500 MCG/ML TO 2000 MCG/ML. THE NURSE CONTACTED THE PT TO RETURN TO CLINIC FOR REPROGRAMMING; LATER THAT DAY THE NURSE CALLED TECHNICAL SVCS AND WAS ASSISTED IN CALCULATING THE VOLUME OF DRUG DELIVERED IN 7.5 HRS AND THE NEW BOLUS VOLUME. THE HCP REPORTED THAT THE PT DID NOT HAVE ANY SYMPTOMS AND WAS DOING FINE.
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 | EXPLANTED| CATHETER MODEL 8709 LOT# N137872012| LOT# NGP310288H| IMPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8637| EXPLANTED |