FDA Adverse Event
Malfunction
Summary report: N
PEAK PULSAR GENERATOR
MDR report key: 2800079
·
Received October 17, 2012
Report
- Report Number
- 3007069406-2012-00234
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- September 20, 2012
- Report Date
- September 20, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K102029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE GENERATOR WAS ABLE TO DELIVER ENERGY WHEN THE RETURN PAD WAS NOT GROUNDED. THE UNIT IS BEING RETURNED TO THE MFR FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE GENERATOR WAS ABLE TO DELIVER ENERGY WITHOUT THE RETURN PAD GROUNDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEAK PULSAR GENERATOR | GEI | MEDTRONIC ADVANCED ENERGY LLC | PULSAR II | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |