FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1213294
·
Received October 27, 2008
Report
- Report Number
- 6000030-2008-06915
- Event Type
- Injury
- Date Received
- October 27, 2008
- Report Date
- September 26, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS "IN PAIN FOR A LONG TIME". WHEN THE PUMP WAS REPLACED, IT WAS FOUND THAT THE CATHETER WAS NOT IN THE SPINAL FLUID. BOTH THE PUMP AND CATHETER WERE REPLACED. FOLLOWING REPLACEMENT, THE PATIENT HAD GOOD PAIN RELIEF. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL UNKNOWN| CATHETER: MODEL8709| EXPLANTED: |