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

Model Number	383578
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 march 2021.
Event or Problem Description
Device showed 53 percent battery longevity on 25-sep-2020, and an eri alert on (b)(6) 2020.Device was explanted and returned for analysis.The device analysis indicated a battery issue.No adverse patient events were reported.

• Brand Name: ILESTO 7 VR-T DF-1 US
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 12339895
• Report Number: 1028232-2021-04631
• Device Sequence Number: 19534607
• Product Code: LWS
• UDI-Device Identifier: 04035479125349
• UDI-Public: 04035479125349
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 03/31/2015
• Device Model Number: 383578
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 41 YR