| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01229-1 |
| Product Name/Description |
REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus Programmers
REPLY DR dual chamber pacemaker
Catalogue Number: ICV1099
ARTG Number:152879
REPLY SR single chamber pacemaker
Catalogue Number: ICV1119
ARTG Number: 158733
ESPRIT DR dual chamber pacemaker
Catalogue Number: ICV1114
ARTG Number:163898
ESPRIT SR single chamber pacemaker
Catalogue Number: ICV1125
ARTG Number:163899 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
There could be overestimation of the residual longevity displayed by the programmer during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemakers. Because of this incorrect information, the follow-up dates might not have been adjusted when nearing the Elective Replacement Indicator (ERI). When the device approaches the ERI, this overestimation of the residual longevity could result in ERI or End Of Life (EOL) being reached between two follow-up visits. Please note that when the devices are programmed at high energy outputs (e.g. high pulse amplitude and width) associated to a high percentage of paced events, longevity can be reduced. No permanent injury or death has occurred as a result of the reported events. In all reported events, pacing functions were maintained at follow-up time. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Sorin CRM is asking clinicians to implement the following patient management recommendations:
- Consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k?, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit.
-When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre.
-As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k?. This recommendation should also be followed subsequent to the installation of the new programmer software version.
A new programmer software version (SmartView 2.40 version or higher) will be released to correct the time to ERI and its presentation through the color-coded gauge. Sorin representative will inform the users as soon as the software upgrade is available.
For more details, please see http://tga.gov.au/safety/alerts-device-orchestra-devices-and-espirit-pacemakers-131129.htm . |
| Contact Information |
1800 452 650 - Sorin Group |