FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1061809
·
Received June 13, 2008
Report
- Report Number
- 2182207-2008-03244
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 16, 2008
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT A MOTOR STALL DUE TO MRI OR OTHER MEDICAL PROCEDURE OCCURRED. THE MOTOR STALL WAS NOTED IN THE PUMP EVENT LOGS; NO MOTOR STALL RECOVERY WAS NOTED. SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE HCP FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | CATHETER MODEL 8709| EXPLANTED:| PROGRAMMER MODEL 8840 |