FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1861120
·
Received October 4, 2010
Report
- Report Number
- 3007566237-2010-07577
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 8, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A MOTOR STALL. THE MOTOR STALL WAS CONFIRMED, AND IT WAS RECORDED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE MOTOR STALL WAS CAUSED BY THE PT HAVING AN MRI OR OTHER MEDICAL PROCEDURE. THERE WAS NO VOLUME DISCREPANCY IN THE DEVICE. ALSO, AN UNDERDOSE WAS REPORTED, AND THE PT WAS HAVING INCREASED PAIN IN THE LEG. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYS WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | CATHETER: MODEL 8709, LOT# J11397R56| IMPLANTED:| EXPLANTED: |