VIGILANT X4 CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2017 · 2 device variants grouped
Total Reports
2,356
Reports (30d)
29
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
System Revision Due to Infection
crt, explanted cardiac, crt revision, reported crt, revision infection
26
reports
Oversensing of Atrial Signals
crt, remains service, effects, technical services, services
15
reports
High Out of Range Shock Impedance Alert
measurements, crt, lead, impedance, range
15
reports
Inappropriate Anti-Tachycardia Pacing Delivery
crt, tachycardia, anti, delivered, atp
9
reports
Intermittent Loss of Capture on LV Lead
crt, remains service, effects, loss capture, capture
8
reports
Device Unable to be Interrogated
defibrillator crt, crt, remains service, effects, technical services
4
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
Jul 7, 2022 · Open, Classified
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Evidence
Related research
Citations indexed from PubMed.
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