INOGEN X4 CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
984
Reports (30d)
10
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion in CRT Device
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
4
reports
CRT Revision Due to Infection
crt, explanted cardiac, crt revision, infection additional, revision infection
3
reports
Shock Lead Impedance High Out of Range
crt, lead, impedance, range, impedance measurements
3
reports
Oversensing of Noisy Signals on Right Ventricular Lead
defibrillator crt, crt, lead, remains service, effects
2
reports
CRT Device Explanted Due to Infection
defibrillator crt, crt, infection, patient complications, result event
1
reports
MRI Mode Not Programmed, Device in Backup Mode
support contacted, resolve event, technical support, mri, mode
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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