FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1021176
·
Received March 28, 2008
Report
- Report Number
- 6000030-2008-01676
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- May 1, 2006
- Report Date
- February 27, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT SINCE HIS PUMP IMPLANT IN 2006, THE PT HAS HAD WALKING AND BALANCING PROBLEMS. THE PT WAS REDIRECTED TO HIS HEALTH CARE PROVIDER. 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 MANUFACTURING | 8590-1 | N063663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863740| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| LOT# NGV016302N| EXPLANTED:| EXPLANTED: |