FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 992404
·
Received February 6, 2008
Report
- Report Number
- 6000030-2008-00558
- Event Type
- Injury
- Date Received
- February 6, 2008
- Report Date
- July 13, 2007
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS RELATED TO MEDTRONIC NEUROMODULATION OFFICE OF MEDICAL AFFAIRS EVENTS AND HAS BEEN DISCUSSED WITH THE REPORTING SYSTEMS MONITORING BRANCH AT FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS EXPERIENCING "LOWER EXTREMITY SENSORY CHANGES AFTER IMPLANT". SPECIFIC SYMPTOMS WERE NOT REPORTED. ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709 | N096554021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | IMPLANTED:| PUMP MODEL #: 8637AA| IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709AA LOT# N096823019| EXPLANTED:| PROGRAMMER MODEL 8840 |