FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202903
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00984
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- March 21, 2008
- Report Date
- March 28, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A MOTOR STALL OCCURRED DURING AN CATHETER IMPLANT/REVISION PROCEDURE. THE LOGS WERE ACCESSED AND REVIEWED. THE STALL AND RECOVERY WERE RECOREDED AT 0904 ON (B)(6)-2008. NO ALARM WAS HEARD. A MAGNETIC RESONANCE IMAGE (MRI) WAS TAKEN IN THE OPERATING ROOM AT THE SAME TIME WHEN THE MOTOR STALL OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302750 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00034 YR |