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

Model Number	393040
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device at eos after multiple shocks for noise on the rv lead.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the eos battery status, 151 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During the analysis of the available iegms, noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in shock delivery, as mentioned in the complaint description.Therefore, a sensing test was performed and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be normal and as expected.The analysis of the shock holter data showed that more than 100 charging cycles were performed by the device within an hour on (b)(6) 2020.As a result of that fast successive charging the eos battery status had occurred.The eos status was removed with a technical programmer and subsequent interrogation revealed the eri battery status.The amount of charge taken from the battery was verified, revealing the eri battery status to be as expected.In a next step, 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 as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the memory content as well as the therapeutic functionality of the icd was extensively analyzed.In the available iegms the occurrence of noise was observed in the right ventricular channel, confirming the clinical observation.This led to fast successive charging cycles that partially resulted in shock deliveries.The activation of the eos status resulted from that fast successive charging.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of a device malfunction.

• Brand Name: ITREVIA 7 VR-T DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10144744
• Report Number: 1028232-2020-02418
• Device Sequence Number: 16939919
• Product Code: LWS
• UDI-Device Identifier: 04035479129552
• UDI-Public: 04035479129552
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 10/31/2016
• Device Model Number: 393040
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 02/01/2021
• 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: 63 YR