FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1024461
·
Received April 3, 2008
Report
- Report Number
- 6000030-2008-01759
- Event Type
- Injury
- Date Received
- April 3, 2008
- Date of Event
- February 1, 2008
- Report Date
- March 6, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
FOUR DAYS AFTER DEVICE IMPLANTATION, THE PATIENT REPORTED THAT HE HAD A PINCHED NERVE. THE HCP REPORTED THAT PLACEMENT OF THE INTRATHECAL CATHETER MAY HAVE CAUSED NERVE IRRITATION AND INCREASED PAIN. AN X-RAY ON 03/2008 SHOWED THAT THE CATHETER WAS COILED; IT WAS REPOSITIONED ON THREE DAYS LATER. THE HCP REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER FENTANYL 300 MCG/ML AT APPROXIMATELY 100 MCG/DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8731SC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED| IMPLANTED| PUMP MODEL #863740 |