| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01223-1 |
| Product Name/Description |
Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
AUTOGEN CRT-D
Model Numbers: G172 / G173 / G175 / G177 / G179
AUTOGEN DR ICD
Model Numbers: D046 / D047 / D176 / D177
ARTG numbers: 221642, 221643, 221640, 221618, 221615, 221616, 221641, 221633, 221617 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific AUTOGEN DR ICDs and CRT-Ds include the option of enabling a Right Ventricular Automatic Threshold (RVAT) test to determine the RV pacing threshold and adjust amplitude in an ambulatory setting. If the RVAT test feature is enabled and noise signals are continuously sensed within a brief RV noise window following an Atrial pace, a patient may not receive effective pacing support until the RVAT test ends (i.e., up to 20 cardiac cycles). Although no patients have been harmed in the cases reported to date, brief periods of dizziness were reported in one case. Note that there is no additional risk for patients in whom the RVAT feature is disabled. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Boston Sci is developing a S/W solution that will prevent this device behaviour from occurring when the RVAT test feature is enabled. Following appropriate regulatory approval, this S/W solution will be implemented via a non-invasive download from the programmer. Until a S/W solution can be implemented, Boston Sci recommends the following: 1)For ambulatory RVAT tests, it is recommended that the RVAT test feature is not enabled in AUTOGEN DR ICDs and CRT-Ds, due to the potential risk of asystole occurring during the RVAT test. If the ambulatory RVAT test feature has been enabled, Boston Sci recommends disabling the RVAT feature at the first opportunity, but within 3 months. 2) For in-clinic/commanded RVAT tests, it is recommended that physicians test thresholds manually, rather than utilising the automatic RVAT test.For more information, please see http://www.tga.gov.au/alert/autogen-dr-implantable-cardioverter-defibrillator-and-autogen-cardiac-resynchronisation-therapy-defibrillator . This action has been closed-out on 18/03/2016. |
| Contact Information |
02 8063 8299 - Boston Scientific Asia Pacific Technical Services |