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

Model Number	392412
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device explanted due to going from 25 percent to eri overnight.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
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 interrogation of the icd revealed the eri battery status.The device was implanted for 72 months and 31 charging cycles were recorded in the devices memory.The icd was subjected to an electrical analysis.The ability of the device to deliver therapies was verified.The anti-bradycardia 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.The shock was not delivered due to a depleted battery.Subsequently, 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 showed a depleted battery.The overall current consumption of the electronic module was directly measured and proved to be normal.There was no indication of a malfunction of the electronic module.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.At a next step, the battery was opened for destructive analysis and the inner assembly was inspected.The analysis identified a short circuit, which led to an increased internal self-depletion and, as a result, to the clinical observation.In conclusion, analysis revealed an increased internal self-depletion within the battery as the root cause of the clinical observation.

• Brand Name: ITREVIA 7 DR-T DF-1
• 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: 12804821
• Report Number: 1028232-2021-06196
• Device Sequence Number: 5511515
• Product Code: MRM
• UDI-Device Identifier: 04035479128807
• UDI-Public: 04035479128807
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 01/31/2017
• Device Model Number: 392412
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2014
• 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: 64 YR
• Patient Sex: Male