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

Model Number 377208

Device Problem Failure to Interrogate (1332)

Patient Problem Syncope/Fainting (4411)

Event Date 09/16/2020

Event Type  Injury  

Event Description

Patient had syncopal episodes and was getting device checked.Device technician was unable to interrogate the device.Device remains implanted.Should additional information become available, this file will be updated.

Manufacturer Narrative

We received your event description for the above mentioned device.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The data returned for analysis were inspected in detail.The inspection revealed that the lv sensitivity in biv-mode was not activated.In this case the lv channel is not recorded and the iegm is discarded.The iegms will be recorded and displayed as soon as the lv sensitivity is activated.Should additional relevant information become available, the investigation will be updated.

• Brand Name: EVIA HF-T
• Type of Device: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10541178
• MDR Text Key: 207158601
• Report Number: 1028232-2020-03945
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 04035479118372
• UDI-Public: 04035479118372
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377208
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR