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

Model Number 393012

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

Device was changed out due to eos.No adverse patient events were reported.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.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.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.

Manufacturer Narrative

Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The device was returned and analyzed.Upon receipt, the device interrogation revealed the eri battery status.The eos status could not be confirmed.The device was implanted for 38 months and 19 charging cycles were recorded in the icds memory.The device was opened to inspect the inner assembly and to check the functionality of the electronic module.Visually no deficiencies were observed.The current consumption of the electronic module was directly measured and found to be elevated.The electronic module was attached to an external power supply to test the functionality of the module.The ability of the electronic module to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.Further electrical investigations revealed that a low voltage capacitor of the electronic module was damaged, causing an increased current consumption, draining the battery.In conclusion, a damaged low voltage capacitor on the electronic module was identified during analysis.There was no sign of any inconsistency during the manufacturing process.It is therefore assumed, that the damage occurred after the device shipment, however the date of occurrence was not determinable.Based on the analysis, it is reasonable to assume that the therapy functionality of the icd was not compromised while implanted and in service.

• Brand Name: INVENTRA 7 HF-T QP DF4 IS4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11590887
• MDR Text Key: 243118721
• Report Number: 1028232-2021-01492
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479129286
• UDI-Public: 04035479129286
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 393012
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/06/2021; 07/06/2021
• Supplement Dates FDA Received: 04/06/2021; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR