FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1170688
·
Received September 16, 2008
Report
- Report Number
- 6000030-2008-05801
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 18, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECENTLY HAD AN MRI AND A PUMP MEMORY ERROR WAS NOTED. SOURCES OF POTENTIAL ELECTROMAGNETIC INTERFERENCE WERE PRESENT.
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 | 60 YR | Required Intervention | PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709 |