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

Model Number 390094

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 06/03/2021

Event Type  Injury  

Event Description

It was reported that approx.53 months after the implantation the rv lead and the associated icd were explanted due to oversensing.The first observation was made while the patient was having surgery on his face and neck and the icd therapies were not disabled.The device gave 2 inappropriate shocks for interference/ noise from diathermy.Since this event, the icd has shown reportedly evidence of noise, recently culminating in an aborted shock episode in (b)(6) 2021.

Manufacturer Narrative

The icd and the lead were received for analysis.The icd was interrogated, revealing the mos1 battery status.The device was implanted for 52 months and 46 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During analysis of the available iegms noise was observed in the ventricular and farfield channels.Therefore a sensing test was performed.The device sensed the attached heart signals free of noise, proving the sensing function of the icd to be normal and as expected.In a next step, 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 fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.The impedance measurement functions of the device were tested and proved to be fully functional.Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized.The analysis revealed that the insulation in the distal end region was found damaged due to wear, which is assumed to be the root cause of the reported oversensing.Based on the characteristics of this damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.Further damages such as a stretched rv shock coil, most likely resulted from the extraction procedure due to tensile stress.The manufacturing processes for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing processes.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the ventricular and farfield channels.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of an icd malfunction.The analysis did not reveal any sign of a material or manufacturing problem of these devices.

• Brand Name: ILESTO 7 VR-T DX PROMRI DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12158648
• MDR Text Key: 261232355
• Report Number: 1028232-2021-03928
• Device Sequence Number: 1
• Product Code: LWS
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 390094
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization