FDA Adverse Event
Injury
Summary report: N
INTRATHECAL CATHETER
MDR report key: 1033618
·
Received April 24, 2008
Report
- Report Number
- 6000030-2008-02177
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 26, 2008
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE SYSTEM WAS EXPLANTED DUE TO MENINGITIS. THE DRUG IN THE PUMP WAS DILAUDID 50 MG/ML. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRATHECAL CATHETER | LKK | RICE CREEK MFG | 8731 | N059611011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | LOT# NGP021489N IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863720| EXPLANTED| EXPLANTED| CATHETER MODEL 8596 LOT# N107390013 IMPLANTED |