Medtronic Advanced Energy LLC - 7/3/2012
Issue Date
Jul 03, 2012
Region
Pacific
Category
Device
$117.00
Address 1
2464 Embarcadero Way
City
Palo Alto
State
CA
Zip/Postal Code
94303
Country
United States
Inspection Range
Jun 18, 2012 - Jul 03, 2012
Pages
6
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Mark E. Chan