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Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is issuing a hazard alert for various models (see below) of its cardiac resynchronisation therapy defibrillators (CRT-Ds) due to the potential for partial loss of therapy in rare circumstances.
Medtronic Australasia will also undertake a recall for product correction of affected models to reprogram the device and correct the issue.
CRT-Ds are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. They can be reprogrammed using external controllers.
Medtronic has received two reports of patients overseas losing therapy in their left ventricles following a particular sequence of reprogramming commands. No injuries had been reported as at 10 November 2016. Medtronic Australasia said available data revealed an overall occurrence rate of 0.38%. There have been no reported incidents in Australia.
The affected models and product codes are:
| Model name | Product code |
|---|---|
| Amplia MRI CRT-D SureScan | DTMB2D1 |
| DTMB2D4 | |
| Amplia MRI Quad CRT-D SureScan | DTMB2QQ |
| Claria MRI CRT-D SureScan | DTMA2D1 |
| DTMA2D4 | |
| Claria MRI Quad CRT-D SureScan | DTMA2Q1 |
| DTMA2QQ |
Information for consumers
Please note that, at this time, the above issue has been confirmed in only a very small proportion (0.38%) of patients implanted with the potentially affected CRT-D devices.
Medtronic Australasia has contacted cardiologists treating patients with potentially affected devices, providing further information about the above issue, including a patient advisory letter.
If you or someone you provide care for has one of these CRT-D devices implanted, your managing health professional will discuss this issue with you and may provide you the patient advisory letter.
If you experience symptoms of returning heart failure, you should contact your cardiologist immediately. Such symptoms could include:
- difficulty breathing
- swelling in the legs or feet
- dizziness
- fatigue.
If you have any questions or concerns about this issue, please contact your cardiologist.
Information for health professionals
If you are treating a patient who has a potentially affected device and is concerned, reassure them that this issue has been confirmed in only a very small proportion of devices implanted (0.38%).
Advise them to be alert to the signs that treatment has ceased, such as decompensation, dizziness, lethargy and dyspnea.
Patients with symptoms suggestive that there has been a partial loss of pacing should be referred to their cardiologist.
Information for cardiologists
Medtronic Australasia has contacted cardiologists who manage patients with potentially affected devices, providing further information about the above issue and how to mitigate it, including a patient advisory letter.
The issue can occur when an implanted device with AdaptivCRT enabled (factory setting) is subsequently programmed to MVP mode and then reprogrammed back to DDD or DDDR. In such cases AdaptivCRT is not re-enabled. When this programming sequence occurs, LV pacing is not delivered, despite parameters indicating AdaptivCRT is enabled. This will result in RV only pacing, which may result in returning heart failure symptoms: decompensation, dizziness, lethargy and dyspnea. LV pacing will remain disabled until a specific reprogramming sequence is manually completed. The full sequence is detailed in the letter sent by Medtronic Australasia dated 14 December 2016.
If you are managing a patient who has a potentially affected device, based on your clinical judgment you should either provide them the patient advisory letter and/or schedule a visit to discuss this issue.
If you have any questions or concerns about this issue, or require further information, contact Medtronic Australasia on 02 9857 9052.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.