FDA Adverse Event
Other
Summary report: N
INTRATHECAL CATHETER
MDR report key: 5004669
·
Received August 14, 2015
Report
- Report Number
- 2182207-2004-00293
- Event Type
- Other
- Date Received
- August 14, 2015
- Report Date
- September 24, 2024
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540783 | INTRATHECAL CATHETER | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8731 | B0022297N66 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention | "SEE H10...."| EXPLANTED: UNK.| IMPLANTED.| PUMP: MODEL 862718, LOT# NGF040121R. |