FDA Adverse Event
Injury
Summary report: N
PERCUTANEOUS INTRASPINAL CATHETER KIT
MDR report key: 1150448
·
Received September 5, 2008
Report
- Report Number
- 2182207-2008-05459
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- April 17, 2008
- Report Date
- August 7, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT A PUMP TRIAL. AFTER THE CATHETER WAS PLACED, THE PT WAS "EXTREMELY UNCOMFORTABLE" IN THE RECOVERY ROOM. THE HCP WAS CONCERNED THAT THE CATHETER MAY HAVE BEEN PLACED INTRATHECALLY RATHER THAN EPIDURALLY, AND SO THAT THE CATHETER WAS REMOVED. THE PT WAS TRANSFERRED TO A HOSPITAL FOR EVALUATION BY A NEUROSURGEON. THE PT WAS OBSERVED FOR A FEW DAYS. WHEN THE PT WAS DISCHARGED, SHE HAD WEAKNESS IN HER LOWER EXTREMITIES AND WAS USING A WALKER. THE HCP WAS CONCERNED THAT THE STIFFNESS OF THE CATHETER MAY HAVE CAUSED TRAUMA TO THE SPINAL CORD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUTANEOUS INTRASPINAL CATHETER KIT | LKK | MEDTRONIC NEUROMODULATION | 8516 | 60952535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |