DYNAGEN X4 CRT-D Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002

Total Reports

918

Reports (30d)

10

Active Signals

1

Open Recalls

1

Monthly Report Volume
Event Type Breakdown

Active safety signals

Disproportionate reportinghigh

FDA recalls for this device

Class II

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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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.