INOGEN CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
308
Reports (30d)
1
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Unable to Interrogate Device
resynchronization, crt, remains service, resynchronization therapy, therapy defibrillator
3
reports
High Out of Range Impedance Measurements
crt, lead, impedance, range, impedance measurements
1
reports
Loss of Capture on Left Ventricular Lead
crt, effects, loss capture, service, capture
1
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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