FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2050194
·
Received April 1, 2011
Report
- Report Number
- 3007566237-2011-02495
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- March 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT UNDERWENT MRI (MAGNETIC RESONANCE IMAGING) ON (B)(6) 2011. A MOTOR STALL OCCURRED AT 1357. A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS APPROXIMATELY 1 HOUR AFTER THE MRI AND NO MOTOR STALL RECOVERY WAS RECORDED. THE NEXT DAY, A PUMP ALARM OCCURRED AND WAS CONFIRMED BY TELEMETRY. THE ALARM WAS DUE TO A MOTOR STALL; THE STALL WAS CONSTANT. THE PUMP CONTAINED MORPHINE 5 MG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 62 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# L78721 |