| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00830-1 |
| Product Name/Description |
Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)
Emblem S-ICDs
Model Numbers: A209 and A219
SQ-RX S-ICD
Model Number: 1010
ARTG Numbers: 260382, 286705 & 219499 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has been informed of a single, isolated S-ICD event that resulted in a device-related patient death in May of 2017. Boston Scientific engineers have determined that this patient’s S-ICD repeatedly delivered an atypical amount of energy (similar to the arrhythmia induction function) because a specific memory location was corrupted by radiation within the environment. This repeated atypical energy delivery prevented S-ICD arrhythmia detection/treatment and ultimately contributed to the patient death.
This device behaviour has been simulated in a laboratory setting by corrupting two specific adjacent bits of device memory on similar model S-ICDs, and the test results correlated with the information available from this event. Although this device behaviour is highly unlikely to reoccur, an S-ICD software update is being developed to mitigate the effects of memory corruption by preventing atypical energy delivery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Boston Scientific are developing a software update (v4.04 or higher) that addresses the behaviour. In the interim, Boston Scientific recommends NO changes to clinical follow-up due to this single event. Specifically, for patients with S-ICD systems:
1. Continue using the S-ICD system to detect and treat life-threatening ventricular tachyarrhythmias;
2. Keep scheduled LATITUDE and/or in clinic follow-ups; and
3. Follow the precautions identified in the S-ICD user’s manual when radiation therapy is prescribed.
Furthermore, Boston Scientific does NOT recommend the following:
4. Early or off-cycle follow-ups are not recommended. This type of memory corruption cannot be detected, thus additional S-ICD checks do not reduce the potential for this device behaviour.
5. Prophylactic S-ICD replacement or explant is not recommended. The risks associated with such an additional surgical procedure significantly outweigh the risk of reoccurrence of this device behaviour.
This action has been closed out on 11/10/2018 |
| Contact Information |
02 8063 8299 - Boston Scientific Technical Services |