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

Model Number 401662

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

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

Event Date 03/13/2022

Event Type  malfunction  

Event Description

Device went from 35 percent to eos on (b)(6) 2022.The device potentially delivered as many as 80 shocks between (b)(6) 2022 and (b)(6) 2022.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.The returned device data have been analyzed.The analysis confirmed the eos battery status.At least 127 charging cycles within 100 minutes were recorded in the devices memory on march 13, 2022.The amount of charge taken from the battery was verified, revealing the eos battery status to be as expected.Analysis of available iegms showed noise in the right ventricular channel, leading to multiple charging cycles (127) that partially resulted in shock deliveries (63) as mentioned in the complaint description.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

Manufacturer Narrative

Device was explanted 18-mar-2022.Upon receipt, the icd was interrogated, revealing the eos battery status.The device was implanted for 70 months and 240 charging cycles were recorded in the icds memory.The amount of charge taken from the battery was verified, indicating the eos battery status to be anticipated.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 shock deliveries, confirming the clinical observation.Therefore, a sensing test was performed, and the device sensed the applied heart signals free of noise, proving the sensing function of the icd to be normal and as expected.There was no indication of a device malfunction.In a next step, the eos status was removed with a technical programmer and 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 defibrillation test was not performed due to the depleted battery status.The current consumption of the icd was normal.In conclusion, in the available iegms the occurrence of noise was observed in the right ventricular channel, which led to multiple shock deliveries, confirming the clinical observation.However, a thorough analysis of the icd did not show any indication of a malfunction.The battery status was anticipated due to the large amount of charging cycles performed by the icd.

• Brand Name: ITREVIA 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: 13792808
• MDR Text Key: 287337105
• Report Number: 1028232-2022-01336
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479138769
• UDI-Public: (01)04035479138769(17)170331
• 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
• Report Date: 03/15/2022

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: 03/31/2017
• Device Model Number: 401662
• 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: 03/15/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/17/2022; 09/02/2022
• Supplement Dates FDA Received: 03/24/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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 Age: 51 YR
• Patient Sex: Female