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

Model Number 393012

Device Problems Premature End-of-Life Indicator (1480); Device Sensing Problem (2917); High Capture Threshold (3266)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

The patient was shocked approximately 20 times.Patient has not transmitted to home monitoring since (b)(6) 2021.On (b)(6) 2021 there is elevated thresholds, decreased sensing and decreased biv and crt pacing as well.When the device was interrogated it was at eos even though the battery percent at last transmission was 72 percent.Unable to tell if the shocks were appropriate or not since the device is at eos.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

(b)(6) 2022 device explanted.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

(b)(6) 2022 device explanted.The icd was returned for analysis.Before analyzing the icd, the manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.Incoming visual inspection revealed electro-cautery and arc-over marks on the icd housing.Upon receipt, the device could not be interrogated.Therefore, the device was opened to inspect the inner assembly and to check the functionality of the electronic module.Analysis of the electronic module showed that an output stage of a high voltage circuit and several other electric components had been damaged.These damages led to an elevated current consumption, which depleted the battery.As a result of the battery depletion and the damages of the electronic module the device could not be interrogated.The battery was sent to the manufacturer for further analysis.In depth inspection of the battery showed no anomalies.Based on the damage symptoms of the electronic module, the damages were most probably caused by an external defibrillation.The exact external root cause is not determinable based on the available information.However, a defective icd can be excluded.

• 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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13122189
• MDR Text Key: 283298064
• Report Number: 1028232-2021-06997
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479129286
• UDI-Public: (01)04035479129286(17)190331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 393012
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 01/10/2022; 04/24/2023
• Supplement Dates FDA Received: 01/06/2022; 01/13/2022; 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male