FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1023482
·
Received April 2, 2008
Report
- Report Number
- 6000030-2008-01734
- Event Type
- Malfunction
- Date Received
- April 2, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 3, 2008
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT'S CATHETER WAS REPLACED DUE TO A BREAK, TEAR, OR HOLE. NO PT SYMPTOMS OR OUTCOME WAS REPORTED. THE PT'S PUMP CONTAINED MORPHINE, FENTANYL, BACLOFEN AND BUPIVICAINE. ADD'L INFO 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 ADD'L INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MFG | 8709 | L81955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | EXPLANTED| IMPLANTED| IMPLANTED| PROGRAMMER MODEL UNK LOT # UNK| IMPLANTABLE INFUSION PUMP MODEL8627-18| EXPLANTED |