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Gallant DR Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

Gallant HF Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

FDAMar 10, 2022Nationwide

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Gallant DR Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Gallant HF Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

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