FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 3082567
·
Received April 29, 2013
Report
- Report Number
- 3007566237-2013-01456
- Event Type
- Injury
- Date Received
- April 29, 2013
- Report Date
- April 2, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD HIS FIRST PUMP REMOVED ABOUT THREE YEARS AGO DUE TO AN INFECTION. IT WAS NOTED THAT IT HAD WORKED WELL FOR HIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183197 | UNKNOWN | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |