RESONATE HF CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
518
Reports (30d)
25
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
CRT Revision Due to Infection
crt, explanted cardiac, crt revision, infection additional, revision infection
16
reports
Difficulty Interrogating CRT Device
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
9
reports
Loss of Capture in Left Ventricular Lead
capture, defibrillator crt, crt, effects, service adverse
6
reports
Inappropriate ATP and Shock for Atrial Driven Arrhythmia
crt, therapy, tachycardia, anti tachycardia, atp
5
reports
Far Field Oversensing on Right Atrial Lead
defibrillator crt, crt, remains service, resynchronization therapy, therapy defibrillator
3
reports
Shock Lead Impedance High Out of Range
crt, lead, impedance, range, impedance measurements
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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