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

Model Number 392426

Device Problem Ambient Noise Problem (2877)

Patient Problem Death (1802)

Event Date 12/03/2018

Event Type  Death  

Event Description

It was reported that the patient had passed away.A biotronik representative was asked to pull up the patients home monitoring information to see if the device had been functioning properly.Home monitoring showed: noise on the rv lead led to vf detection but no therapy was delivered.Decreased sensing amplitude was also noted.It appears that the vf was not true and there were signs of possible artifacts.Biotronik is trying to recover the device for an analysis.At this time the device remains in the body.

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.

• Brand Name: ITREVIA 7 DR-T DF4
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 8171818
• MDR Text Key: 130609233
• Report Number: 1028232-2018-04226
• Device Sequence Number: 0
• Product Code: NIK
• 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
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 392426
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 02/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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 Outcome(s): Death
• Patient Age: 77 YR