FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 2060939
·
Received March 14, 2011
Report
- Report Number
- 6000030-2011-01895
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 22, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PUMP MEMORY ERROR OCCURRED. THERE WERE SOURCES OF POTENTIAL ELECTROMAGNETIC INTERFERENCE PRESENT. THE PUMP WAS PROGRAMMED TO STOP PUMP. THE PUMP INFO WAS RE-CHECKED AND WAS CORRECT; THE PUMP WAS UPDATED AND THE ISSUE WAS RESOLVED.
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 | 54 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# L66218 |