MEDTRONIC, INC. · Ventricular Assist Device (LVAD)
Total Reports
995
Reports (30d)
12
Active Signals
0
Open Recalls
69
What the reports describe · Claripulse analysis
Damaged Driveline Cable
driveline, normal, damage, device vad, cable
5
reports
Patient Death with Unknown Causes
right, implantation, patients, bleeding, death
4
reports
Low Flow Alarms with Device in Use
right, log file, low, device vad, vad remains
3
reports
Cut in Driveline Sheath
log files, driveline, damage, pump, cable
3
reports
Patient Passed Away, Device Functioned
passed away, related, considered device, patient passed, death
2
reports
Driveline Infection Requiring IV Treatment
data registry, information likely, device analysis, device vad, possible information
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
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