HVAD Pump Implant Kit Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Ventricular Assist Device (LVAD) · First cleared Nov 2012 · 3 device variants grouped
Total Reports
37,651
Reports (30d)
22
Active Signals
0
Open Recalls
69
What the reports describe · Claripulse analysis
Most commonly reported problems
Motor Start Event with Low Flow Alarms
vad, complications, use, device vad, vad remains
43
reports
Template Summary: LVAD Outcomes with RVAD Support
outcomes, survival, patients, study, group
18
reports
Data Registry: VAD Outcomes Tracking
data registry, outcomes, vad, intermacs, device vad
7
reports
Driveline Sheath Damage from Wear
vad, damage, use, device vad, remains
7
reports
Patient Death with Unknown Cause
device therapy, passed away, therapy related, outcome, patient passed
6
reports
Driveline Infection Leading to Pump Exchange
driveline infection, infection, therapy, surgical, patients
5
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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