Bluetooth circuit component issue which can:
1. disable Bluetooth telemetry (including remote monitoring) and,
2.result in high current consumption leading to reduced device longevity.
ANZCDACC Management Recommendations for Abbott Product Defect Correction
August 2023
Device:
GALLANT™, NEUTRINO™ NXT, and ENTRANT™ ICDs and CRT-Ds manufactured prior to April 2022
(Models CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q and CDHFA300Q)
Note: No affected NEUTRINO™ NXT or ENTRANT™ ICDs and CRT-Ds were implanted in Australia.
No affected GALLANT™ or NEUTRINO™ NXT ICDs and CRT-Ds were implanted in NZ.
TGA Reference:
RC-2023-RN-00734-1