Device was not able to send a test message via home monitoring.Multiple cardiomessengers were used, multiple programmers were used, all troubleshooting steps were taken.This device was reset and it will still not transmit to a cardiomessenger.The device functions normally otherwise.On (b)(6) 2016 - device is still not transmitting in home monitoring.
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We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
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