A subset of devices with a manufacturing defect are susceptible to increased noise due to moisture affecting the electrode performance.
Device:
Medtronic LINQ II Implantable Cardiac Monitor (LNQ22)
TGA Reference:
RC-2023-RN-00930-1
Australian Register of Therapeutic Goods (ARTG):
391830 and 355313
ANZCDACC Management Recommendations for Medtronic LINQ II Alert
November 2023
Software issue which can lead to loss of device sensing.
ANZCDACC Management Recommendations for Boston Scientific EMBLEM S-ICD Alert
October 2023
Device: EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD A219
TGA Reference: RC-2023-RN-00850-1
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
Reduced or no-energy output during HV therapy in ICDs/CRT-Ds manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
ANZCDACC Hazard Alert and Product Defect Correction May 2023
Device:
Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds
A subset of: Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava™ CRT-Ds
A subset of: Visia AF™/Visia AF MRI™/Evera™/Evera MRI™/Primo MRI™/Mirro MRI™ ICDs
TGA Reference:
RC-2023-RN-00433-1
A laser surface preparation may not have properly prepared the device’s metal housing potentially leading to abnormal device-to-header adhesion which may allow moisture ingress into the header.
ANZCDACC Product Hazard Alert July 2022
Device: A subset of Assurity™, Endurity™ and Zenex™ Pacemakers
MODELS: PM2162, PM2172, PM2272, PM2282*
* TGA Approved but not currently commercially released
TGA Reference:
RC-2022-RN-01000-1
Potential for shocks to be ~79% of the programmed energy as a result of a safety feature, Short Circuit Protection, designed to truncate delivered energy to protect the device when unexpected current is detected during HV therapy.
ANZCDACC Hazard Alert June 2022
Device:
Medtronic Cobalt XT™, Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
TGA Reference: RC-2022-RN-00811-1
Australian Register of Therapeutic Goods (ARTG):
339481, 339482, 339483, 339484, 339485, 339486, 339487, 339488, 339489, 339490, 339491, 339492, 341547, 341548, 341549, 341551, 341552, 341555, 341556, 341557, 341558, 341553, 341550, 341554
May encounter a persistent “session-active” flag following the use of inductive telemetry, typically with CareLink Express. This will result in temporary suspension of some features until the flag is cleared:
ANZCDACC Hazard Alert May 2022
Device:
Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
TGA Reference: RC-2022-RN-00608-1
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
Rarely SmartSync interrogation sessions, or CareLink network transmissions may fail for Cobalt or Crome devices when the current session diagnostic data includes any VT/VF episode type with multiple therapy sequences and three or more data recording suspensions. SmartSync will display “Unexpected error occurred”, and the app. requires restarting. Within CareLink, the current transmission processing may fail, and the information will not be viewable.
ANZCDACC Report: Medtronic Cobalt™ and Crome™ Product Defect Correction October 2021
Device:
All Medtronic Cobalt™ and Crome™ ICDs and CRTDs.
Cobalt™: Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DDPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Crome™: Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1
TGA /Medsafe Reference:
TGA: RC-2021-RN-02064-1
Australian Register of Therapeutic Goods (ARTG): 313620
Medsafe Reference: 28468
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
