FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1180917
·
Received September 23, 2008
Report
- Report Number
- 6000030-2008-06042
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 28, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT RECENTLY HAD AN MRI. THE PUMP HAD A PUMP MEMORY ERROR. THEY WERE ABLE TO SUCCESSFULLY REINITIALIZE THE PUMP. NO PT SYMPTOMS WERE REPORTED. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORTED WILL BE SENT IF ADDITIONAL INFO 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 | 47 YR | CATHETER: MODEL 8709| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER |