FDA Adverse Event
Malfunction
Summary report: N
RF MULTIGEN
MDR report key: 1911465
·
Received November 17, 2010
Report
- Report Number
- 1811755-2010-01747
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 26, 2010
- Report Date
- October 26, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K032601
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
DURING AN RF PROCEDURE OF LEVELS C4, C5, AND C6, WHEN THE GENERATOR SWITCHED TO MOTOR STIMULATION MODE, THE PATIENT EXPERIENCED UNINTENTIONAL SENSORY STIMULATION. THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT AND WITHOUT DELAY. THERE WAS NO INTERVENTION OR ADDITIONAL TREATMENT REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF MULTIGEN | GENERATOR, LESION, RADIOFREQUENCY | GXD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |