MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA NEO 7 VR-T DF-1 PROMRI; ICD

Model Number	429531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An automatic email notification was received regarding an adverse event that occurred during the dx-af study.Database information was forwarded and is summarized below.The diagnosis/cause was tamponade and was determined to be moderate severity and the symptoms included decrease of blood pressure.The corrective action taken was pericardial puncture.The event resulted in in-patient hospitalization on (b)(6) 2021.The outcome of the event is on-going and the relationship of the adverse event to medical device is not related to the icd or lead implant but related to the implantation procedure as indicated on the study database.Patient was observed for 24 hours post pericardial puncture and patient was released on (b)(6) 2021.
Additional Manufacturer Narrative
We received your event description for the above mentioned devices and would like to thank you for supporting our post-market surveillance.As of today, the medical devices are not available for analysis, therefore the devices themselves 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 become available, the investigation will be updated.

• Brand Name: ILIVIA NEO 7 VR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11416460
• Report Number: 1028232-2021-01067
• Device Sequence Number: 17097576
• Product Code: LWS
• UDI-Device Identifier: 04035479156763
• UDI-Public: 04035479156763
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 429531
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization