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

Model Number	383580
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
This device alerted eri via home monitoring on (b)(6) 2018.An analysis of the device data indicated that the device should be replaced.It was explanted and replaced on (b)(6) 2018.
Additional Manufacturer Narrative
Upon receipt, the device interrogation revealed the eos battery status, detected on (b)(6) 2018.The device was implanted for 47 months and 17 charging cycles were recorded in the devices memory.The current consumption of the icd was analyzed and found to be normal and as expected.However, an inconsistency between current consumption and battery voltage was noted.Therefore, the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage confirmed a depleted battery.In a next step, the electronic module was attached to an external power supply and the eos status was removed with a technical programmer to check the functionality of the electronic module.There was no indication of a malfunction, particularly all therapy functions were available and worked as expected.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 battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis.The visual inspection of the battery did not reveal any external signs of damage.The measurement of the battery voltage confirmed a depleted battery and the microcalorimetry analysis showed an elevated heat dissipation.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified damaged insulation, which led to the elevated internal self-depletion.In conclusion, the device was implanted for 47 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.

• Brand Name: ILESTO 7 VR-T DF4
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8084573
• Report Number: 1028232-2018-03994
• Device Sequence Number: 1599073
• Product Code: LWS
• UDI-Device Identifier: 04035479125363
• UDI-Public: (01)04035479125363
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 03/31/2016
• Device Model Number: 383580
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 07/29/2019
• 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: 67 YR