| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00077-1 |
| Product Name/Description |
Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)
ARTG Number: 260383 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for radio frequency (RF) interference to alter wireless communication from the Model 3200 programmer, which in rare instances may cause an S-ICD to perform an unintended command, such as the unintended initiation of PG-based tachyarrhythmia induction of a patient, or a command that results in therapy being unavailable after the telemetry session has ended, both of which could result in patient death. This behaviour can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behaviour occurring when the Latitude Patient Management System communicates with an S-ICD in an ambulatory setting. To date, a total of ten observations of unintended programming commands or data changes have been observed, with no instances of permanent injury or death. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Boston Scientific is developing software to mitigate this issue. Until updated software is available, recommendations that mitigate the risks associated with this issue, and which are detailed in the customer letter, are to be followed.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 8063 8299 - Boston Scientific Technical Services |