FDA Adverse Event
Malfunction
Summary report: N
INDURA CATHETER
MDR report key: 1003504
·
Received February 21, 2008
Report
- Report Number
- 6000030-2008-00818
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Report Date
- January 21, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTED A LEAK WAS FOUND IN HER IMPLANTED SYSTEM, BUT SHE DID NOT KNOW THE LOCATION OF THE LEAK. THE PATIENT'S PUMP WAS REPLACED TO EXTEND THE LENGTH OF TIME BETWEEN REFILLS. THE PATIENT REPORTED SHE DID NOT BELIEVE THAT HER CATHETER WAS REPLACED. THE PATIENT'S PUMP CONTAINED MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA CATHETER | LKK | RICE CREEK MANUFACTURING | 8709 | J11888R27 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNKNOWN |