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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 Insufficient Information (3190)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Event Description
Ous mdr - patient is a (b)(6) female and is currently having issues with her blood pressure, chf and avb. Since the day of implant a decrease in blood pressure was noted from 70 to 50 every day at 2 am. At that point the av-delay became long, up to 300. The staff used a working demo to work out simulations to find alternative settings, which was unsuccessful. They were able to reproduce the event and it was noted that when the home monitoring transmission time was changed from 2 am to 3am, the time of the occurrence changed as well.
 
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Brand NameEVIA HF-T
Type of DeviceCRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM D-12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key5398934
MDR Text Key37138411
Report Number1028232-2016-00208
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 01/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number377208
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/29/2016 Patient Sequence Number: 1
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