MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 DR-T PROMRI DF-1; ICD

Model Number 390068

Device Problem Failure to Interrogate (1332)

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

Event Date 03/21/2020

Event Type  malfunction  

Event Description

It was reported that approx.31 months after the implantation the device could not be interrogated.The device was replaced.

Manufacturer Narrative

Upon receipt, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.In a next step, the icd was opened and the inner assembly was inspected.The inspection revealed that some components of the electronic module had been damaged, resulting in a permanent high current condition that finally depleted the battery.Based on the observed damage symptoms, it is reasonable to assume that the damages were caused by strong external electromagnetic fields, like a magnetic resonance imaging (mri).If a charging cycle occurs in a strong external magnetic field, depending on strength and orientation, a saturation of the high voltage transformer may appear, leading to a temporary high current condition.This induced high current condition may possibly led to such rare events, like the observed damages of the electronic module and does not represent a device malfunction.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the observed damage characteristics.Particularly the final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.

• Brand Name: ILESTO 7 DR-T PROMRI DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10925185
• MDR Text Key: 218909241
• Report Number: 1028232-2020-05194
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 390068
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization