MOMENTUM X4 CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
620
Reports (30d)
10
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
High Out of Range Impedance Measurements
crt, lead, impedance, range, impedance measurements
6
reports
Inappropriate ATP and Shock Delivered
crt, therapy, tachycardia, delivered, atp
3
reports
CRT Revision Due to Infection
crt, explanted cardiac, crt revision, revision infection, crt explanted
3
reports
CRT Explanted for Unspecified Reason
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, crt explanted
2
reports
CRT Explanted Due to Infection
resynchronization, crt, infection, patient complications, result event
2
reports
Oversensed Signals Inhibiting Pacing
defibrillator crt, cardiac resynchronization, crt, therapy defibrillator, resynchronization therapy
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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