ASKU

IMPLANTABLE PULSE GENERATOR

This device is manufactured by MEDTRONIC, MEDTRONIC MILACA, PLEXUS MANUFACTURING SDN BHD, RICE CREEK MANUFACTURING, RICE CREEK MFG and others.

The following problems were reported about this device:

Year Description Events/year Type
2024 Pericardial Effusion 1 Patient
2024 Chest Pain 1 Patient
2024 Cardiac Tamponade 1 Patient
2024 Use of Device Problem 1 Device
2024 Unexpected Shutdown 1 Device
2024 No Display/Image 2 Device
2024 No Device Output 1 Device
2024 Device Sensing Problem 1 Device
2024 Adverse Event Without Identified Device or Use Problem 1 Device
2023 Insufficient Information 1 Patient
2023 Use of Device Problem 2 Device
2023 Output Problem 5 Device
2023 No Device Output 2 Device
2023 Mechanical Problem 3 Device
2023 Device Sensing Problem 3 Device
2023 Crack 1 Device
2023 Calibration Problem 3 Device
2023 Battery Problem 1 Device
2022 Use of Device Problem 3 Device
2022 Unexpected Shutdown 4 Device
2022 Output Problem 1 Device
2022 No Display/Image 3 Device
2022 No Device Output 1 Device
2022 Mechanical Problem 1 Device
2022 Mechanical Jam 1 Device
2022 Loose or Intermittent Connection 1 Device
2022 Failure to Power Up 1 Device
2022 Failure to Capture 1 Device
2022 Display or Visual Feedback Problem 1 Device
2022 Device Contamination with Body Fluid 1 Device
2022 Corroded 1 Device
2022 Contamination 1 Device
2022 Connection Problem 1 Device
2022 Calibration Problem 1 Device
2022 Break 2 Device
2021 Connection Problem 1 Device
2021 Break 1 Device