HEARTWAR VENTRICULAR ASSIST SYSTEM PUMP/DRIVELINE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Ventricular Assist Device (LVAD)
Total Reports
1,015
Reports (30d)
0
Active Signals
0
Open Recalls
69
What the reports describe · Claripulse analysis
Most commonly reported problems
Driveline Infection Requiring Pump Exchange
driveline infection, infection, therapy, surgical, patients
3
reports
Driveline Sheath Damage with Repair
vad, damage, use, device vad, remains
3
reports
Motor Start Event with Low Flow Alarms
vad, complications, use, device vad, vad remains
3
reports
Template Summary: LVAD Outcomes Analysis
outcomes, survival, patients, study, group
3
reports
Data Registry: VAD Outcomes Tracking
data registry, outcomes, vad, intermacs, device vad
1
reports
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
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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