FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1040504
·
Received May 9, 2008
Report
- Report Number
- 6000030-2008-02516
- Event Type
- Injury
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 16, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S CATHETER WAS LEAKING AT THE DISTAL END. THE CATHETER WAS OUT OF THE SPINAL CANAL. THE PT HAD A CSF LEAK. THE LAST 17 CM OF THE CATHETER WERE REPLACED. IT WAS INDICATED THAT THE PT BELIEVED HE WAS STILL GETTING SOME EFFECT, BUT HE FELT THE CATHETER WAS LEAKING AS WELL. THE PHYSICIAN PLANNED TO MAINTAIN THE CURRENT DOSE. THE CONCENTRATION AND DAILY DOSE OF LIORESAL BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709SC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 8840 LOT# UNK| LOT# NGP311528H| IMPLANTABLE INFUSION PUMP MODEL 863720| IMPLANTED| EXPLANTED |