FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1930284
·
Received November 24, 2010
Report
- Report Number
- 3007566237-2010-09930
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- November 18, 2010
- Report Date
- November 18, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-0591-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A CONFIRMED MOTOR STALL WITH NO MOTOR STALL RECOVERY WAS NOTED IN THE EVENT LOGS. THE MOTOR STALL WAS CAUSED BY THE PATIENT HAVING AN MRI. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | CATHETER: MODEL 8709, LOT# N056537006| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N056250| IMPLANTED:| EXPLANTED: |