FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1090663
·
Received August 1, 2008
Report
- Report Number
- 6000030-2008-04568
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 5, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH THE FOLLOWING SYMPTOMS: SOMNOLENCE AND SHORT TERM MEMORY LOSS. THE HCP DOESN'T BELIEVE THAT THE SYMPTOMS ARE RELATED TO THE MEDICATION IN THE PUMP, BUT SHE MAY EMPTY THE PUMP, TO SEE IF IT HELPS THE SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| CATHETER MODEL 8709 LOT# J11599R57| EXPLANTED:| EXPLANTED:| CATHETER MODEL 8731 LOT# N001281607| IMPLANTED:| IMPLANTED: |