MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 5 VR-T DF4; ICD

Model Number	393059
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Codes	Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)
Date of Event	06/06/2019
Type of Reportable Event	Death
Event or Problem Description
Device reached eos after delivering 153 cardioversion therapies by the detection of appropriate vt/vf.The device was successfully replaced.Patient is deceased, date of death is unknown.Death was not device related.
Additional Manufacturer Narrative
Upon receipt, the device was interrogated, revealing the battery status eos.The device was implanted for 24 days and 153 charging cycles were recorded to the device memory.The inspection of the memory content revealed that the eos status was activated on (b)(6) 2019, after the device performed more than 100 charging cycles, most of which resulted in shock deliveries.The analysis of the available iegms showed that this large amount of charging cycles was appropriate and resulted from the detection of intrinsic heart signals.In a next step, the device was subjected to an electrical analysis.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.The battery condition was found to be as anticipated.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 correct sensing and shock delivery.In particular, the specified energy level was reached.There was no indication of a device malfunction.In conclusion, the device proved to be fully functional during analysis.The eos status of the device resulted from successive charging of defibrillation shocks.There was no indication of a material or manufacturing problem.

• Brand Name: ITREVIA 5 VR-T DF4
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9776155
• Report Number: 1028232-2020-01031
• Device Sequence Number: 3068022
• Product Code: LWS
• UDI-Device Identifier: 04035479129743
• UDI-Public: 04035479129743
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 393059
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: Death