MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 7 DR-T DF4 PROMRI; ICD

Model Number 404632

Device Problem Ambient Noise Problem (2877)

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

Event Date 06/11/2021

Event Type  malfunction  

Event Description

It was reported that this device was explanted and replaced due to noise.The physician tested the leads on the analyser, but noise was only detected when the device was connected.An issue with the device header is suspected.

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.As a first step in the analysis, the device was interrogated.The interrogation could be properly performed, and it revealed the battery status eri.Further analysis of the icd memory content showed a normal current consumption.However, the device was received and analyzed.The icd was interrogated, revealing the mos1 battery status.An amount of 17 charging cycles was recorded in the devices memory.The memory content of the icd was inspected.The available iegms revealed the presence of noise in the ventricular and farfield channels, which led to one shock delivery.Subsequently the header of the device was inspected in detail.The inspection revealed an intermittently opened connection as root cause for the clinical observation.As a result of this event, processes have been reviewed and relevant staff has been retrained.In accordance to biotroniks post-market surveillance system this occurrence represents a very rare event.The information you provided has been entered into our quality system and will be used to evaluate the device performance throughout our organization to maintain and improve the design and performance of our devices.

• Brand Name: INTICA 7 DR-T DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12013672
• MDR Text Key: 256758895
• Report Number: 1028232-2021-03403
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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: 04/30/2019
• Device Model Number: 404632
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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