Patient with cardiac arrest at home.Suddenly reported he could not breathe, passed out and had seizure like activity.2 effective, 7 ineffective shocks from icd.Subject died.The last shock, the vt was terminated.Prior to the final and effective shock the patient was going in and out of vt.Should additional information become available, this file 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 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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