FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202937
·
Received July 2, 2013
Report
- Report Number
- 2182207-2013-00001
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- August 4, 2005
- Report Date
- March 29, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PROBLEM WAS REPORTED. HCP REPORTED A MOTOR STALL ERROR MESSAGE OCCURRED WHEN THEY INTERROGATED PUMP WITH MAGNET. MOTOR STALL OCCURRED 11 MINUTES AGO AND RECOVERED 6 MINUTES LATER. HCP INADVERTENTLY USED MAGNET TO INTERROGATE SM II CAUSING MOTOR STALL. IT WAS EXPLAINED TO THE HCP THE USE OF A MAGNET CAUSES THE PUMP MOTOR TO STALL. MOTOR STALL CAUSED BY MAGNETIC INTERFERENCE. THIS WAS NORMAL PUMP FUNCTION. NO CONSEQUENCES TO THE PATIENT WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302393 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |