FDA Adverse Event
Malfunction
Summary report: N
PULSAR GENERATOR
MDR report key: 2821336
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00357
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Report Date
- February 7, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K082786
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE REPRESENTATIVE INFORMED MEDTRONIC THE UNIT WOULD BE RETURNED; HOWEVER, AS OF (B)(4) 2012, THE UNIT HAS NOT BEEN RETURNED. IF THE GENERATOR IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THE COAGULATION WAS WEAK AND THERE WAS A LOUD NOISE. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSAR GENERATOR | GEI | MEDTRONIC ADVANCED ENERGY LLC | PULSAR II | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PLASMABLADE |