FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1030954
·
Received April 17, 2008
Report
- Report Number
- 6000030-2008-02021
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 21, 2008
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A SEROMA DUE TO A DISCONNECTED CATHETER. DYE AND ROTOR STUDIES WERE PERFORMED AND REPORTED TO BE NORMAL. THE SEROMA WAS DRAINED, BUT THE SUBSEQUENTLY UNDERWENT A POCKET REVISION IN 2008 WITH CATHETER REPLACEMENT DUE TO "OCCLUSION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MFG | 8709SC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTABLE INFUSION PUMP MODEL 863740| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8832 LOT # NJG005395N| LOT #NGV410782H |