ATTAIN STARFIX

IMPLANTABLE PACING LEAD

This device is manufactured by MEDTONIC, MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO.

The following problems were reported about this device:

Year Description Events/year Type
2019 Adverse Event Without Identified Device or Use Problem 1 Device
2018 Unstable Capture Threshold 1 Device
2018 Premature Elective Replacement Indicator 1 Device
2018 Positioning Problem 1 Device
2018 Low impedance 1 Device
2018 Impedance Problem 1 Device
2018 High impedance 1 Device
2018 High Capture Threshold 3 Device
2018 Fracture 1 Device
2018 Difficult or Delayed Positioning 1 Device
2018 Capturing Problem 2 Device
2018 Battery Problem 1 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device
2017 Structural Problem 1 Device
2017 Impedance Problem 1 Device
2017 High Capture Threshold 2 Device
2017 Failure to Capture 3 Device
2017 Device Sensing Problem 1 Device
2017 Capturing Problem 1 Device
2017 Appropriate Term/Code Not Available 1 Device
2016 Pocket Stimulation 1 Device
2016 Material Integrity Problem 1 Device
2016 High Capture Threshold 1 Device
2016 Difficult to Remove 1 Device
2016 Device Handling Problem 1 Device
2016 Break 1 Device
2016 Adverse Event Without Identified Device or Use Problem 1 Device
2015 Appropriate Term/Code Not Available 1 Device
2014 Low impedance 1 Device
2014 High Capture Threshold 5 Device
2014 Failure to Capture 2 Device
2014 Device Operates Differently Than Expected 1 Device
2014 Device Dislodged or Dislocated 2 Device
2014 Capturing Problem 4 Device
2014 Appropriate Term/Code Not Available 2 Device
2014 Activation, Positioning or Separation Problem 1 Device
2013 Shelf Life Exceeded 1 Device
2013 High Capture Threshold 1 Device
2013 Appropriate Term/Code Not Available 2 Device
2013 Adverse Event Without Identified Device or Use Problem 1 Device
2011 High Capture Threshold 1 Device
2011 Failure to Capture 1 Device
2011 Capturing Problem 1 Device
2011 Adverse Event Without Identified Device or Use Problem 1 Device