RESONATE X4 CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2017
Total Reports
2,107
Reports (30d)
35
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Oversensing of Atrial Signals
crt, remains service, effects, technical services, services
16
reports
High Out of Range Shock Impedance Alert
measurements, crt, lead, impedance, range
13
reports
Inappropriate Anti-Tachycardia Pacing Delivery
crt, tachycardia, anti, delivered, atp
10
reports
System Revision Due to Infection
crt, explanted cardiac, crt revision, reported crt, revision infection
8
reports
Intermittent Loss of Capture on LV Lead
crt, remains service, effects, loss capture, capture
5
reports
Patient Reports Issues Post-Implant
result event, defibrillator crt, cardiac, crt, patient complications
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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.
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