MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 HF-T DF-1; CRT-D

Model Number 393014

Device Problem Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 13 months and 18 charging cycles were recorded to the device memory.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel.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 fully functional.There was no indication of a device malfunction.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.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.

Event Description

This device was explanted due to physician telling patient it could be the rv lead that was causing noise, or the device.Patient insisted the device be changed when the lead revision was done.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

We received the manufacture date and closing codes.

• Brand Name: ITREVIA 7 HF-T DF-1
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8159621
• MDR Text Key: 130185709
• Report Number: 1028232-2018-04271
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479129309
• UDI-Public: (01)04035479129309
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

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
• Device Operator: Health Professional
• Device Model Number: 393014
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR