Device product

Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

Z-0988-2022

March 10, 2022

Class II

Product summary

Firm: St. Jude Medical, Cardiac Rhythm Management Division
Event: Event 89825
Status: Ongoing
Classification: Class II
Quantity: 1
Official record key: device-enforcement:Z-0988-2022

Official wording

Reason: 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.

Code information: REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.