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

Model Number 404621

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

Patient Problem Pneumothorax (2012)

Event Date 04/23/2019

Event Type  Injury  

Event Description

Left-side pneumothorax was noted following implant of this system.Patient was treated with chest tube placement and the pnuemothorax was confirmed resolved by chest x-ray on (b)(6) 2019.System remains actively implanted.Should additional information become available, 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.As of today, the medical device is not available for analysis, therefore the device itself 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 or the device itself become available, the investigation will be updated.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8638523
• MDR Text Key: 146034503
• Report Number: 1028232-2019-02125
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479142087
• UDI-Public: 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: 05/13/2019

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 Expiration Date: 05/31/2020
• Device Model Number: 404621
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR