FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1052934
·
Received May 23, 2008
Report
- Report Number
- 6000030-2008-02797
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 23, 2008
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD DEVELOPED A 6MM GRANULOMA THAT WAS DIAGNOSED BY MRI. THE PT WAS ASYMPTOMATIC. THE DRUG IN THE PUMP WAS MORPHINE AT 4.8MG/DAY AT AN UNSPECIFIED CONCENTRATION. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U 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 MFG | 8711 | J11354R06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTABLE INFUSION PUMP MODEL 8472-35-05| LOT# NEN111874N| EXPLANTED |