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

Model Number	383578
Medical Device Problem Codes	Premature Elective Replacement Indicator (1483); Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt, the device history record was reviewed, documenting that the device performed as expected during the device manufacturing.In a next step the icd was subjected to an electrical analysis.First, the current consumption of the device was analyzed and found to be normal and as expected.Subsequently, the ability of the device to deliver therapies was verified.The antitachycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device detected the fibrillation signal as specified and started the charging of a defibrillation shock.However, the charging was aborted due a depleted battery.Therefore, the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The electronic module was attached to an external power supply to check its functionality.There was no indication of a malfunction, particularly all therapy functions were available and worked as expected.Therefore, the battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated with this battery.The visual inspection of the battery did not reveal any external signs of damage.The voltage measurement confirmed the battery depletion.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified damaged insulation, which led to an increased internal self depletion within the battery and therefore contributed to the clinical observation.In conclusion, the device was implanted for 40 months.The therapeutic functionality of the device was tested with an attached external power supply and proved to be fully functional.The analysis revealed an increased internal self-depletion within the battery that contributed to the clinical observation.
Event or Problem Description
This device reported eri status on (b)(6) 2019.In (b)(6) of 2018, in office interrogation showed battery longevity of 85%.The device was explanted on (b)(6) 2019 due to eri.Based on the analysis results received from the manufacturer on (b)(4) 2019, this event is reportable.

• Brand Name: ILESTO 7 VR-T DF-1 US
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9082633
• Report Number: 1028232-2019-04044
• Device Sequence Number: 2752599
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: 11/30/2016
• Device Model Number: 383578
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/18/2019
• 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: 56 YR