Author: Martha McCall

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

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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

Hardware component which can cause battery overconsumption at implant and MRI

ANZCDACC Advisory Notice 7th September 2017

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Device: LivaNova (Formerly Sorin Group) Platinium™ ICDs and CRTDs

TGA Reference: RC-2017-RN-00913-1

ANZCDACC Advisory Notice 24th May 2017

Device:  LivaNova  Ovatio, Paradym RF and Intensia ICD’s and CRT’s

Boston Scientific Model 3200 S-ICD Programmer

ANZCDACC Advisory Notice 20th January 2017

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Advisory Grade TGA: TBA (Hazard Alert (Recall for product correction))

ANZDACC Advisory Grade: Routine

Description: Potential RF interference during programmer interrogation of S-ICD with potential to cause temporary and/or permanent unintended programming changes. Latitude remote monitoring not affected.

Ten observations of unintended programming have been reported.
One inappropriate shock and therapy programmed off in another device. One device returned to nominal factory settings.

Risk: Overall risk of adverse event is calculated at 1/25,000 in 5 years for EMBLEM devices and 1/200,000 in 5 years for SQ-RX devices.

In Australia there are 385 devices affected and New Zealand 93 devices.

Presentation: Patients with inappropriate shocks, failure to deliver therapy due to unintended programming (therapies off), unexpected programming changes on home monitoring or at routine review.

Advice: A software update will be released at a future date to rectify this issue. Home monitoring is recommended and if a programmer needs to be used that the device should be reinterrogated immediately after ending session to ensure that there hasn’t been any unintended programming.

Use remote monitoring for routine follow up where ever possible. Reduce frequency of in clinic checks while following medical society guidelines.

Do not leave patient unattended in clinic while an active telemetry session is in progress. Ensure external defibrillation equipment and appropriately trained staff are readily available during in office follow up.

Minimize duration of programmer communication and end telemetry session promptly.

Contact Boston Scientific technical services for assistance should unintended programming occur.

Device:  Medtronic  Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4