FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1052743
·
Received May 23, 2008
Report
- Report Number
- 2182207-2008-02791
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- May 14, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT EXPERIENCED UNSPECIFIED COGNITIVE SYMPTOMS AND HYPERTONIA. THE CATHETER WAS REPLACED DUE TO AN UNSPECIFIED CATHETER MALFUNCTION. THE PT RECOVERED WITHOUT SEQUELA. THE CATHETER WAS USED TO DELIVER LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | MEDTRONIC NEUROMODULATION | 8709 | N098115005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 8840| IMPLANTABLE INFUSION PUMP MODEL 863720| EXPLANTED| LOT# NGP305170H |