FDA Adverse Event
Injury
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3874771
·
Received June 16, 2014
Report
- Report Number
- 3007566237-2014-01665
- Event Type
- Injury
- Date Received
- June 16, 2014
- Report Date
- May 27, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP SYSTEM WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS STILL IMPLANTED AS IT WAS NOT AFFECTED. IT WAS STATED THAT THEY ONLY REMOVED THE CATHETER. THE SPINAL INFECTION WAS AS A RESULT OF A SPINAL SURGERY. IT WAS NOTED THAT THE INFECTION WAS CLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352538 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |