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

Model Number 393037

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Device explanted due to eri with unexpected battery behavior.No adverse patient events were reported.Should additional information be received, this file will be updated.

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 device interrogation revealed the eos battery status, detected on (b)(6) 2022.The device was implanted for approximately 72 months and 28 charging cycles were recorded in the devices memory.The icd was subjected to an electrical analysis.First, the eos status was removed with a technical programmer and 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 delivered a defibrillation shock.Due to the depleted state of the battery the charging time was observed to be longer and the shock energy lower than expected.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 confirmed 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.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.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, an elevated internal self-depletion within the battery was found to be the root cause for the clinical observation.

• Brand Name: ITREVIA 7 VR-T DX
• Type of Device: 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: 16820555
• MDR Text Key: 314083422
• Report Number: 1028232-2023-02124
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 04035479129521
• UDI-Public: (01)04035479129521(17)161031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 393037
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male