FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1133623
·
Received August 20, 2008
Report
- Report Number
- 6000030-2008-05101
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- July 22, 2008
- Report Date
- July 22, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S PUMP "AUTOMATICALLY" TURNED OFF UPON WAKING UP IN THE MORNING. THE PATIENT WENT TO THE HCP TO HAVE THE PUMP TURNED BACK ON. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 70 YR | EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# L55917| PROGRAMMER MODEL PROGRAMMER LOT#UNKNOWN |