MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 HF-T DF-1 PROMRI; CRT-D

Model Number 393013

Device Problem Low impedance (2285)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported that the shock impedance was too low (20 ohms).Ineffective max shock delivered.Device currently remains implanted.Should additional information be received, this file will be update.

Manufacturer Narrative

The icd and the lead were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices, as well as on the returned device data.The quality documents accompanying the manufacturing process for the devices were reviewed.All production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test of the devices proved the device functions to be as specified.The returned device data was inspected.During inspection of the available iegm of episode 942, the clinical observation could be confirmed.The iegm showed a regular detected vf episode with three documented charging cycles of the high voltage capacitors.The first and the second charging cycle was aborted, as expected, due to the detection of a shock impedance smaller than 20 ohms.The third charging cycle led to a regular shock delivery, which, however, did not lead to the termination of the vf.Please note, that the icd is equipped with a safety feature that ensures that no high energy shock is delivered in the event of a detected short circuit, which would otherwise damage the icd.This device behavior does not represent a device malfunction.Based on the analysis, no conclusion could be drawn regarding the exact root cause of the clinical observation.However, it is reasonable to assume that the event resulted from an insulation damage of the lead characterized by an intermittent occurrence of a short circuit in the high-energy conduction path.Therefore, an extensive check and possible revision of the lead should be considered as a result of this event.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.

• Brand Name: ITREVIA 7 HF-T DF-1 PROMRI
• 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: 18270532
• MDR Text Key: 329757035
• Report Number: 1028232-2023-06153
• Device Sequence Number: 1
• Product Code: NIK
• 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: 12/07/2023

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: 03/31/2018
• Device Model Number: 393013
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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