FDA Adverse Event
Malfunction
Summary report: N
MULTIGEN RADIOFREQUENCY GENERATOR
MDR report key: 2758208
·
Received September 18, 2012
Report
- Report Number
- 1811755-2012-03545
- Event Type
- Malfunction
- Date Received
- September 18, 2012
- Date of Event
- August 21, 2012
- Report Date
- August 21, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- GXD
- PMA / PMN Number
- K071482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE DEVICE WAS TURNED TO THE STIMULATION BUTTON THE UNIT WOULD SHOCK THE PT. THE PROCEDURE WAS CANCELED. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIGEN RADIOFREQUENCY GENERATOR | GXD | STRYKER INSTRUMENTS, INSTRUMENTS DIV. | LES5496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |