FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2250616
·
Received September 9, 2011
Report
- Report Number
- 3007566237-2011-07663
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- January 1, 2011
- Report Date
- August 19, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL WITH NO RECOVERY. THE MOTOR STALL WAS CAUSED BY AN MRI. THE PT WAS IN THE HOSPITAL AT THE TIME THE EVENT WAS REPORTED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |