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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVIA HF-T CRT-P

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BIOTRONIK SE & CO. KG EVIA HF-T CRT-P Back to Search Results
Model Number 377208
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/24/2019
Event Type  Death  
Event Description
The patient is expired. The family is questioning functionality of the device. The device has not been received for analysis.
 
Manufacturer Narrative
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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Brand NameEVIA HF-T
Type of DeviceCRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key11015486
MDR Text Key221706644
Report Number1028232-2020-05501
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number377208
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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