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

Model Number	392426
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device shows eri with unexpected battery behavior.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
On (b)(6) 2023, the device was explanted.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
(b)(6) 2023 the device was explanted.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 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 mos2 battery status.Battery trend data showed a temporary voltage drop followed by recovery of the battery voltage.An unexpected battery voltage trend could be confirmed during analysis.Please note, that this icd is subjected to the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: ITREVIA 7 DR-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: 17320270
• Report Number: 1028232-2023-03502
• Device Sequence Number: 15075055
• Product Code: MRM
• UDI-Device Identifier: 04035479128944
• UDI-Public: (01)04035479128944(17)170930
• 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: 2023
• 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): 08/28/2023

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: 09/30/2017
• Device Model Number: 392426
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 08/28/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2015
• 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: 63 YR
• Patient Sex: Male