FDA Adverse Event
Injury
Summary report: N
INTRATHECAL CATHETER
MDR report key: 884802
·
Received July 24, 2007
Report
- Report Number
- 2182207-2007-02312
- Event Type
- Injury
- Date Received
- July 24, 2007
- Report Date
- May 14, 2004
- Manufacturer
- NEUROLOGICAL DIVISION, MEDTRONIC INC
- 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
.
Description of Event or Problem · 1
UBOGU EE, ET AL. TRANSVERSE MYELITIS ASSOCIATED WITH ACINETOBACTER BAUMANII INTRATHECAL PUMP CATHETER-RELATED INFECTION. REG ANESTH PAIN MED. 2003; 28, 5: 470-474.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRATHECAL CATHETER | LKK | NEUROLOGICAL DIVISION, MEDTRONIC INC | CATHETER | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention | INFUSION PUMP, UNK| EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK |