If “Hold to Test” pressed and released prior to first voltage decrement, the programmer may continue the Decrement Test instead of terminating the test.
Device: Abbott: Merlin™ Patient Care System (PCS) Software Model 3330 v25.0.X–v25.3.X
GTIN 05414734509725
When used with: Abbott Gallant™, Neutrino™ NxT, Entrant™ devices
TGA Reference:
Australian Register of Therapeutic Goods (ARTG): 124262
After partial electrical reset, usually after DCCV or electrocautery, Brady & Pause events appear to be “ON,” but are no longer able to detect / report.
ANZCDACC Product Defect Correction and Implant Hazard Alert June 2021
Device: Medtronic Reveal LINQ™ with TruRhythm™ Cardiac Monitoring Systems
TGA Reference: RC-2021-RN-01276-1
Australian Register of Therapeutic Goods (ARTG): 218791
Advisory grade TGA: Class II
(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)
ANZDACC Advisory Grade: Routine
May have compromised performance of an electrical component causing accelerated battery depletion
Device:
ARTG:
TGA Reference: RC-2019-RN-01242-1
Potential for lithium plating in battery that may cause a battery drain at a higher rate than under typical use.
ANZCDACC Safety Alert Notice 21 March 2021 (Download pdf)
Device: Biotronik: Ilesto™, Inventra™, Iperia™, Itrevia™, Ilivia™, Intica™, Intica Neo™ ICDs and CRT-D implanted since 2013
TGA Reference: RC-2021-RN-00667-1
Sept 2021: This is the same alert (RC-2019-RN-01641-1) which has been reclassified by the TGA to an “implant hazard alert”. No change from previous advice or risk: Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion
4 Feb 2021: Update to RC-2019-RN-01641-1 Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion
Updated in 4 Feb 2021 below (see purple text)
Link to previous notification: ANZCDACC Product Notification Notice 22 November 2019
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TGA Reference: RC-2019-RN-01641-1
Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion
ANZCDACC Product Notification Notice 22nd November 2019
Device: Medtronic: Subset of CRT-Ds and ICDs
May have compromised performance of an electrical component causing accelerated battery depletion
ANZCDACC Product Defect Correction Notice August 2019
Device:
ARTG:
TGA Reference: RC-2019-RN-01242-1
