This system was explanted and replaced.No reason was given.Attempts to obtain the information have been unsuccessful.Should additional information become available, this event will be updated.There were no adverse patient side effects reported.Should additional information become available, this event will be updated.
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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 itselfcould 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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