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

Model Number	383580
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device is at eri indication with unexpected battery behavior.No adverse patient events were reported.Should additional information be received, this file will be updated.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.
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
Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.As a first step in the analysis, the device was interrogated.The interrogation could be properly performed and it revealed the eos battery status, detected after explantation of the device.The device was implanted for approximately 88 months.Next, the icd was subjected to an analysis of the electrical parameters.The current consumption of the icd was checked and found to be normal and as expected.Analysis of the battery condition, however, showed an inconsistency of charge taken from the battery and the battery voltage.A premature battery depletion could be confirmed during analysis.Please note, this icd is affected by the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: ILESTO 7 VR-T DF4
• 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: 15412815
• Report Number: 1028232-2022-04716
• Device Sequence Number: 12235862
• Product Code: LWS
• UDI-Device Identifier: 04035479125363
• UDI-Public: (01)04035479125363(17)160831
• 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: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 08/31/2016
• Device Model Number: 383580
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 12/15/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 09/14/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2015
• 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: 76 YR
• Patient Sex: Male