FDA Adverse Event
Malfunction
Summary report: N
INDURA CATHETER
MDR report key: 1000737
·
Received February 15, 2008
Report
- Report Number
- 2182207-2008-00766
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Report Date
- January 25, 2005
- Manufacturer
- NEUROLOGICAL DIVISION, MEDTRONIC, INC.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
THE HCP REPORTED THAT THE PT WAS VERY SPASTIC AND NOT GETTING GOOD RELIEF. THE HCP REPORTED THAT THE PT HAD RELIEF OF SYMPTOMS DURING TRIAL WITH A 50 MCG BOLUS. THE INITIAL DOSING WAS 50 MCG/DAY OF 500 MCG/ML. THE DOSE WAS SLOWLY TITRATED TO 365 MCG/DAY. ESTIMATED RESERVOIR VOLUME WAS 3.2 ML; ACTUAL RESERVOIR VOLUME WAS 24 ML. DYE STUDY INDICATED KINKED CATHETER - DATE UNK. A CATHETER REVISION WAS SCHEDULED FOR 2005. SEE MFR NUMBER: 2182207200500169.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA CATHETER | LKK | NEUROLOGICAL DIVISION, MEDTRONIC, INC. | 8709 | J12057R01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |