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

Model Number	460162
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Pericardial Effusion (3271)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by biotronik, or its employees that the device, biotronik, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Biotronik will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Per bio-conduct study, pt presented to the ed for chest pain for 2 weeks that worsened, radiates across chest, up into shoulders and states that it hurts to breathe.Activity and lying flat makes it worse.Lab-troponin i <0.012(0-.120ng/ml).Btnp-461(<125pg/ml).Chest xr-cardiomegaly, no acute findings.Ct chest-moderate pericardial effusion, admitting pt.Treated with colchicine and tylenol, heart tones remained easily audible and vs stable, repeat limited echo showed medium size pericardial effusion mainly posterior & lateral to the heart with max 2.5cm thickness, no evidence of tamponade.Pt observed for another night and discharged home with follow up.Dc01/18@1044am.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: AMVIA EDGE HF-T QP
• Common Device Name: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24744206
• Report Number: 1028232-2026-01616
• Device Sequence Number: 8780424
• Product Code: NKE
• UDI-Device Identifier: 04035479174002
• UDI-Public: (01)04035479174002(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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 Expiration Date: 09/30/2026
• Device Model Number: 460162
• Device Catalogue Number: 460162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown