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 02/26/2021

Event Type  malfunction  

Event Description

Noise on lead caused delivery of 51 inappropriate shocks, causing eos.Should additional information become available, it will be added to this file.

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.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the eos battery status.The icd was implanted for 38 months and 108 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During the analysis of the available iegms, noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in shock delivery.Therefore, a sensing test was performed and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be normal and as expected.The analysis of the shock holter data showed that a large amount of charging cycles was performed by the device within one and a half hours on (b)(6) 2021.As a result of that fast successive charging the eos battery status had occurred.The eos status was removed with a technical programmer and subsequent interrogation revealed the eri battery status.The amount of charge taken from the battery was verified, revealing the eri battery status to be as expected.In a next step, the ability of the device 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.In conclusion, the memory content as well as the therapeutic functionality of the icd was extensively analyzed.In the available iegms the occurrence of noise was observed in the right ventricular channel, confirming the clinical observation.This led to fast successive charging cycles that partially resulted in shock deliveries.The activation of the eos status resulted from that fast successive charging.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of a device malfunction.

• 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: 11401755
• MDR Text Key: 234394786
• Report Number: 1028232-2021-01028
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 393012
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR