Device would not interrogate despite normal troubleshooting and multiple programmers.Magnet response normal, 75% battery remaining, and device transmitting to hm with no alerts.Patient undergoing radiation treatment.The device remains implanted.Technical services recommended device explant but as of (b)(6) all available information suggests this device remains implanted.
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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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