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

Model Number	404622
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device is at eri indication with unexpected battery behavior.No adverse patient events reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
The device was explanted on (b)(4) 2024.The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
The device was explanted on (b)(6) 2024.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly, and the final acceptance test proved the device functions to be as specified.Next, the device was interrogated.The interrogation could be properly performed and revealed the mos1 battery status.Battery trend data showed an unexpected voltage drop that resulted in the observed activation of the eri battery status.Based on the characteristics of the voltage drop a temporary short circuit within the battery was confirmed, compromising the integrity of the battery.Please note, that this icd is subjected to the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: ILIVIA 7 DR-T DF-1 PROMRI
• 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: 20064877
• Report Number: 1028232-2024-04493
• Device Sequence Number: 18074658
• Product Code: MRM
• UDI-Device Identifier: 04035479142094
• UDI-Public: (01)04035479142094(17)200731
• 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: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2024

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: 07/31/2020
• Device Model Number: 404622
• Device Catalogue Number: 404622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/28/2024; Not provided; 10/18/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/04/2024; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2019
• 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: 48 YR
• Patient Sex: Male