FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1001705
·
Received February 15, 2008
Report
- Report Number
- 6000030-2008-00705
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Date of Event
- January 7, 2008
- Report Date
- January 16, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE PATIENT REPORTED, A CATHETER FRACTURE HAD OCCURRED (EXACT DATE WAS NOT PROVIDED); SUBSEQUENTLY, THE SYSTEM WAS REMOVED. NO SYMPTOMS OR OUTCOME WAS PROVIDED. THE DRUG USED IN THE PUMP WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8703 | J93117819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | LOT# NGG001966R| IMPLANTED| PROGRAMMER MODEL UNK| EXPLANTED| IMPLANTABLE NEUROMODULATION PUMP MODEL 8627L10| IMPLANTED |