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

Model Number	383562
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to eos.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the eos battery status.The device was implanted for approximately 92 months and 134 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During the analysis of the available iegms, noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in shock deliveries.The inspection of the shock holter data showed that an amount of 63 charging cycles were performed by the device within 30 minutes on (b)(6) 2022.As a result of that fast-successive charging the eos battery status had occurred.The eos status was removed with a technical programmer and subsequent interrogation revealed the eri battery status.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found 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.In conclusion, in the available iegms the occurrence of noise was observed in the right ventricular channel.This led to fast successive charging cycles that partially resulted in shock deliveries.The activation of the eos status resulted from that fast-successive charging.However, there was no indication of an icd malfunction.

• Brand Name: ILESTO 7 DR-T DF-1
• Common Device Name: 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: 14188259
• Report Number: 1028232-2022-02077
• Device Sequence Number: 4481905
• Product Code: MRM
• UDI-Device Identifier: 04035479125189
• UDI-Public: 04035479125189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 383562
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 11/14/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 04/26/2022; 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male