FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2211129
·
Received August 8, 2011
Report
- Report Number
- 3007566237-2011-06127
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S CRITICAL ALARM WAS SOUNDING. TELEMETRY CONFIRMED THE ALARM. THE ALARM WAS DUE TO A MOTOR STALL AND THE STALL WAS CONSTANT. THE PT HAD NOT HAD ANY MRI'S AND WAS IN BED AT THE TIME THE STALL OCCURRED. THE PT'S WAS DOING OKAY AT THE TIME THE EVENT WAS REPORTED, BUT HIS PAIN IS UP A LITTLE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS COMPOUNDED BACKLOFEN. ADD'L INFO HAS BEEN REQUESTED, A F/U 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 | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | IMPLANTED:| CATHETER: MODEL 8709, LOT# J0058164R| EXPLANTED: |