It was reported that the device was explanted due to shows the eri status.Should additional information be received, this file will be updated.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.
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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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