FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1800900
·
Received August 10, 2010
Report
- Report Number
- 3007566237-2010-06004
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 13, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- 860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT A CATHETER WAS INADVERTENTLY PULLED OUT OF THE EPIDURAL SPACE DURING A SPINAL/SCOLIOSIS SURGERY. THE PHYSICIAN WAS ABLE TO THREAD THE CATHETER BACK TO ITS CORRECT POSITION. LIORESAL WAS BEING ADMINISTERED VIA THE PUMP, HOWEVER, CONCENTRATION AND DAILY DOSE INFORMATION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED:| EXPLANTED: |