FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202942
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00988
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- November 5, 2008
- 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).
Additional Manufacturer Narrative · 1
SUPPLEMENTAL SUBMITTED TO CORRECT ON PREVIOUS REPORT 3007566237-2013-00988. THE REPORTED MOTOR STALL WAS NOT ON (B)(6) 2008 BUT IN (B)(6) 2008.
Description of Event or Problem · 1
A PROBLEM WAS REPORTED. ON (B)(6) 2008, HCP REPORTED A PROBLEM RELATED TO A PUMP. A MOTOR STALL WAS REPORTED. CONFIRMED MOTOR STALL AND MOTOR STALL RECOVERY RECORDED IN EVENT LOGS. MOTOR STALL CAUSED BY HCP USING MAGNET WHEN TRYING TO TELEMETRY TO THE PUMP. NO SYMPTOMS REPORTED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED AT THE TIME. IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300841 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR |