FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 1022164
·
Received March 26, 2008
Report
- Report Number
- 2182207-2008-01609
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Report Date
- April 2, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE, KRACH, LE ET AL. "SATISFACTION OF INDIVIDUALS TREATED LONG-TERM WITH CONTINUOUS INFUSION OF INTRATHECAL BACLOFEN BY IMPLANTED PROGRAMMABLE PUMP. "PEDIATRIC REHABILITATION. 2006. 9(3): 210-218. TWELVE EVENTS OF CATHETER OBSTRUCTION, MIGRATION OR FRACTURE WERE EXPERIENCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | LKK | MEDTRONIC NEUROMODULATION | CATHETER | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| LOT# UNKNOWN| IMPLANTABLE INFUSION PUMP MODEL PUMP| EXPLANTED: |