FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202974
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00983
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- July 26, 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. 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. REASSURED THAT PUMP WAS WORKING PROPERLY. 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 |
|---|---|---|---|---|---|---|---|
| 300988 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |