MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 HF-T QP DF4 IS4 PROMRI; ICD

Model Number 404621

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Pleural Effusion (2010)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient experienced pain around implant site.Physician noted slight erythema around the site.Hematoma had been noted at discharge.Patient received an x-ray, which revealed small pleural effusions.No definite signs of infection were observed.Pressure dressing was applied to the site, but no surgical intervention was reported.The system remains actively implanted and the event is considered ongoing.Should additional information be received, this file will be updated.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.The device is currently not available for analysis.Therefore, no conclusion can be drawn at this time.However, biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.Should additional relevant information become available, this investigation will be updated.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8389835
• MDR Text Key: 137801357
• Report Number: 1028232-2019-00966
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479142087
• UDI-Public: (01)04035479142087
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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
• Device Operator: Health Professional
• Device Model Number: 404621
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR