DYNAGEN CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
404
Reports (30d)
1
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate ATP and Shock for Atrial Driven Arrhythmia
crt, therapy, tachycardia, anti tachycardia, atp
2
reports
Shock Lead Impedance High Out of Range
crt, lead, impedance, range, impedance measurements
2
reports
CRT Revision Due to Infection
crt, explanted cardiac, crt revision, revision infection, crt explanted
1
reports
Inappropriate Shock Delivered by ICD
implantable cardioverter, icd, cardioverter, cardioverter defibrillator, inappropriate
1
reports
Patient Deceased with Unknown Cause
defibrillator crt, fibrillation, crt, therapy, ventricular tachycardia
1
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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