FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1040033
·
Received May 7, 2008
Report
- Report Number
- 6000030-2008-02449
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 10, 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
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER DISLODGED FROM THE INTRATHECAL SPACE. PT SYMPTOMS INCLUDED CEREBROSPINAL FLUID LEAK, SPINAL HEADACHE, HYPERTONIA, AND INCREASED SPASMS. THE CATHETER WAS PUT BACK INTO THE INTRATHECAL SPACE DURING A REVISION SURGERY (DATE NOT REPORTED). THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL; THE PT WAS GIVEN ORAL BACLOFEN FOR HIS SYMPTOMS. THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709 | J10856R27 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT# NGP029150N| IMPLANTABLE INFUSION PUMP MODEL 863720| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER MODEL # 8596SC |