FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1031332
·
Received April 18, 2008
Report
- Report Number
- 6000030-2008-02073
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- January 1, 2007
- Report Date
- March 21, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
A CATHETER DYE STUDY DONE IN 2007 REVEALED A CATHETER KINK. CATHETER REVISION SURGERY WAS PLANNED, BUT NO DATE HAD BEEN SET. THE PT WAS HAVING NO PAIN RELIEF. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709 | N096561007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| PUMP MODEL # 863740| PROGRAMMER MODEL 8840 LOT# UNK |