Boston Scientific Model 3120 Zoom(TM) programmer (December 2023)

Incorrect dates are displayed on certain pacemaker models using the Model 3120 Zoom (TM) programmer following January 10, 2024.

ANZCDACC management recommendations for Boston Scientific Zoom programmer alert (December 2023)

Download pdf here

Device:

Boston Scientific Model 3120 ZoomTM Programmer running software Model 2892

TGA Reference:  RC-2023-RN-01030-1

Australian Register of Therapeutic Goods (ARTG):  123599

Medsafe Notification Reference:  32214

Advisory grade TGA:  Class II

Medtronic – LINQ II ™ implantable cardiac monitor (Nov 2023)

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

Download PDF

Abbott: GALLANT™, NEUTRINO™ NXT, and ENTRANT™ ICDs and CRT-Ds manufactured prior to April 2022 (August 2023)

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

Download PDF

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

 

 

Medtronic Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds (May 2023)

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

Download as pdf

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

 

Abbott: Subset of Assurity™, Endurity™ and Zenex™ Pacemakers (July 2022)

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

  Download as pdf

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

Medtronic Cobalt XT™, Cobalt™ and Crome™ ICDs and CRT-Ds (June 2022)

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

Download as pdf

 

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

Medtronic Cobalt™ and Crome™ ICDs and CRT-Ds (May 2022)

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

(Download as pdf)

Device:

Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)

 TGA Reference: RC-2022-RN-00608-1

Abbott: Merlin™ Patient Care System (PCS) Software used in Gallant™, Neutrino™ NxT, Entrant™ devices (March 2022)

If “Hold to Test” pressed and released prior to first voltage decrement, the programmer may continue the Decrement Test instead of terminating the test.

Download as pdf

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

 

Medtronic Cobalt™ and Crome™ ICDs and CRTDs (Oct 2021)

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

Download as pdf

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

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