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

Model Number	393040
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device showed eos during follow up and has incorrect dates for last follow up of 2002.Battery voltage currently shows 2.98v.Device currently remains implanted.Should additional information be obtained, this report will be updated.
Additional Manufacturer Narrative
Device explanted (b)(6) 2020.
Additional Manufacturer Narrative
Device explanted (b)(6) 2020.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.The device interrogation revealed the eos battery status, confirming the clinical observation.The device was implanted for 46 months and 21 charging cycles were recorded in the devices memory.The icd was subjected to an electrical analysis.The current consumption of the icd was found to be normal and as expected.However, an inconsistency between current consumption and battery voltage was noted.In order to obtain further insights, the icd was opened and the inner assembly was inspected.The visual inspection showed no anomalies.Subsequently the current consumption of the electronic module was verified by direct measurement and proved to be as expected and consistent with the interrogated icd data.There was no indication of a malfunction of the electronic module.Therefore the battery was disconnected from the electronic module and sent to the manufacturer for further analysis.During analysis of the battery lithium plating was identified, which led to an elevated internal self-depletion and, as a result, to the clinical observation.Please note, this icd is affected by the field safety corrective action, bio-lqc, initiated in (b)(6) 2021.

• Brand Name: ITREVIA 7 VR-T DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10601640
• Report Number: 1028232-2020-04151
• Device Sequence Number: 3158610
• Product Code: LWS
• UDI-Device Identifier: 04035479129552
• UDI-Public: 04035479129552
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2020

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: 12/31/2016
• Device Model Number: 393040
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 08/16/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/02/2020; 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR