SCREW-IN

IMPLANTABLE PACING LEAD

This device is manufactured by MEDTRONIC, MEDTRONIC PUERTO RICO, RICE CREEK MANUFACTURING, RICE CREEK MFG, ST JUDE MEDICAL.

The following problems were reported about this device:

Year	Description	Events/year	Type
2024	Insufficient Information	2	Patient
2023	Unspecified Infection	2	Patient
2023	Insufficient Information	1	Patient
2023	Output Problem	1	Device
2023	Low impedance	1	Device
2023	High Capture Threshold	2	Device
2023	Failure to Capture	2	Device
2023	Electrical /Electronic Property Problem	1	Device
2023	Adverse Event Without Identified Device or Use Problem	2	Device
2022	Undesired Nerve Stimulation	3	Patient
2022	Failure of Implant	2	Patient
2022	Signal Artifact/Noise	1	Device
2022	Pacing Problem	1	Device
2022	Insufficient Information	2	Device
2022	Inappropriate/Inadequate Shock/Stimulation	2	Device
2022	Impedance Problem	2	Device
2022	High impedance	1	Device
2022	High Sensing Threshold	2	Device
2022	High Capture Threshold	2	Device
2022	Failure to Capture	2	Device
2022	Defective Component	4	Device
2021	Unspecified Infection	3	Patient
2021	Insufficient Information	6	Patient
2021	Erosion	1	Patient
2021	Pacing Problem	1	Device
2021	Insufficient Information	4	Device
2021	High Sensing Threshold	1	Device
2021	High Capture Threshold	2	Device
2021	Failure to Capture	1	Device
2021	Adverse Event Without Identified Device or Use Problem	1	Device
2020	Tachycardia	1	Patient
2020	Insufficient Information	1	Patient
2020	Under-Sensing	1	Device
2020	Signal Artifact/Noise	1	Device
2020	Over-Sensing	2	Device
2020	Noise, Audible	2	Device
2020	Insufficient Information	1	Device
2020	Incorrect, Inadequate or Imprecise Result or Readings	1	Device
2020	High impedance	1	Device
2020	High Sensing Threshold	1	Device
2020	Failure to Capture	1	Device
2020	Appropriate Term/Code Not Available	1	Device