FDA Adverse Event
Injury
Summary report: N
UNKNOWN PUMP
MDR report key: 1061424
·
Received June 17, 2008
Report
- Report Number
- 2182207-2008-03286
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 19, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
AFTER PLACING THE CATHETER, IT WAS NOTICED THAT THE CATHETER WAS LEAKING. IT WAS IMMEDIATELY DECIDED TO REPLACE THE CATHETER WITH A NEW ONE. THERE WAS NO PATIENT INJURY. AFTER THE REPLACEMENT, THE PATIENT WAS DOING FINE AND GETTING APPROPRIATE PAIN RELIEF. THE PUMP WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PUMP | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8731SC LOT# N148771| EXPLANTED| IMPLANTED |