FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202922
·
Received July 2, 2013
Report
- Report Number
- 2182207-2013-00005
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- February 15, 2006
- Report Date
- March 28, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
A PROBLEM WAS REPORTED. HCP REPORTED A MOTOR STALL AND RECOVERY DUE TO USING TELEMETRY MAGNET ON SMII PUMP. THE STALL WAS RECORDED IN TELEMETRY LOGS. STALL RECOVERED. IT WAS REPORTED THE PUMP WAS WORKING FINE AFTER RECOVERY. NO PATIENT SYMPTOMS WERE REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302381 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00014 YR |