FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE CATHETER
MDR report key: 3033479
·
Received April 3, 2013
Report
- Report Number
- 3007566237-2013-01015
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Report Date
- May 13, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PATIENT REPORTED THAT THEIR HEALTHCARE PROVIDER WAS AWARE OF 'INSTANCES WHERE MORPHINE HAD CRYSTALLIZED AROUND THE CATHETER.' THE EVENT WAS NOTED TO NOT HAVE OCCURRED WITH THE PATIENT'S SYSTEM, BUT WITH AN UNKNOWN NUMBER OF PATIENT'S SYSTEMS. NO SYMPTOMS WERE REPORTED, AND NO PATIENT OUTCOMES WERE PROVIDED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135702 | UNKNOWN IMPLANTABLE CATHETER | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_CATH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |