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

Model Number	377208
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10541178
• Report Number: 1028232-2020-03945
• Device Sequence Number: 3161244
• Product Code: NKE
• UDI-Device Identifier: 04035479118372
• UDI-Public: 04035479118372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 377208
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR