FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 5108265
·
Received December 30, 2004
Report
- Report Number
- 5108265
- Event Type
- Injury
- Date Received
- December 30, 2004
- Date of Event
- July 28, 2004
- Report Date
- November 22, 2004
- Manufacturer
- MEDTRONIC INC YSA
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MIGRATED INTRATHECAL CATHETER AND LOOSE DRUG ADMINISTRATION PUMP IN THE ABDOMINAL POCKET. MEDICAL MANAGEMENT OF ACUTE OPIOID WITHDRAWAL AND DISPLACED INTRATHECAL CATHETER. CSF LEAK. INTRATHECAL CATHETER WAS REPLACED AND DRUG ADMINISTRATION PUMP WAS RESUTURED. MFR: 6000030-2004-01771.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | INTRATHECAL CATHETER | LKK | MEDTRONIC INC YSA | 8731 | B009449N30 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |