FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1061978
·
Received June 16, 2008
Report
- Report Number
- 6000030-2008-03254
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- June 27, 2007
- Report Date
- May 19, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VOLUME DISCREPANCY WAS NOTED AT REFILL. THE EXPECTED RESERVOIR VOLUME WAS 13 ML; THE HCP ASPIRATED 11 ML FROM THE RESERVOIR. ON THE DATE OF THAT REFILL, THE INTRATHECAL DOSE OF GABALON WAS INCREASED FROM 200 MCG/DAY TO 230 MCG/DAY FOR SPASM CONTROL. TWO SUBSEQUENT REFILLS WERE PERFORMED AND THE VOLUME DISCREPANCIES WERE REPORTED TO BE WITHIN NORMAL LIMITS (<25%).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| EXPLANTED:| CATHETER MODEL 8711 LOT# N077018012 |