FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE PUMP
MDR report key: 4200556
·
Received October 24, 2014
Report
- Report Number
- 3007566237-2014-03112
- Event Type
- Injury
- Date Received
- October 24, 2014
- Report Date
- October 1, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD READ THAT ¿OTHERS HAVE HAD THE PIECE OF CATHETER THAT HAD TRAVELED INTO THE BRAIN AND THEY WERE SAVED¿. NO FURTHER INFORMATION WAS PROVIDED INCLUDING WHO THE PATIENTS WERE OR THEIR DEVICE INFORMATION, WHAT CAUSED THESE EVENTS, IF ANY ACTIONS OR INTERVENTIONS WERE TAKEN OR THE PATIENTS¿ OUTCOMES. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO OBTAIN THE PATIENTS¿ MANAGING HEALTH CARE PROVIDERS (HCPS) INFORMATION BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678482 | UNKNOWN IMPLANTABLE PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |