FDA Adverse Event
Injury
Summary report: N
PROXIMAL CATHETER
MDR report key: 1051673
·
Received May 21, 2008
Report
- Report Number
- 2182207-2008-02713
- Event Type
- Injury
- Date Received
- May 21, 2008
- Date of Event
- February 1, 2008
- Report Date
- April 22, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN LATE 2007, THE PT UNDERWENT CATHETER REPLACEMENT. THE OLD CATHETER WAS TIED OFF AND LEFT IN PLACE. IN 2008, THE PT EXPERIENCED SWELLING NEAR THE CATHETER PATHWAY. THE PT EXPERIENCED A CSF LEAK WITH INTERMITTENT EDEMA AT THE BACK INCISION DUE TO LEAKAGE FROM THE RETAINED CATHETER FRAGMENT. THE RETAINED CATHETER WAS REMOVED DURING WOUND EXPLORATION. THE PT RECOVERED WITHOUT SEQUELA. THE PATIENT'S PUMP CONTAINED FENTANYL 2600 MCG/ML AT 1100 MCG/DAY AND BUPIVACAINE 24 MG/ML AT 10 MG/DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMAL CATHETER | LKK | MEDTRONIC NEUROMODULATION | 8596 | N093105002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTABLE INFUSION PUMP MODEL 863720| LOT # NGP028678N IMPLANTED| EXPLANTED |