MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 HF-T QP DF4 IS4; CRT-D

Model Number	401662
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This icd was replaced during an rv lead revision because the set screw was not securing firmly.A new crtd was implanted.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status mos2.The icd was implanted for about 55 months and 26 charging cycles were recorded to the device 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 two charging cycles that resulted in one shock delivery.However, there was no indication of a device malfunction.The header of the icd was visually inspected, revealing no anomalies.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.The set screws showed screw marks on the bottom side indicating that they were tightened during the implantation.There was no indication of a material or manufacturing problem.In conclusion, the device was fully functional.There was no indication of a device malfunction.

• Brand Name: ITREVIA 7 HF-T QP DF4 IS4
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11060038
• Report Number: 1028232-2020-05642
• Device Sequence Number: 1046387
• Product Code: NIK
• UDI-Device Identifier: 04035479138769
• UDI-Public: 04035479138769
• 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): 12/22/2020

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: 05/31/2017
• Device Model Number: 401662
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2015
• 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
• Patient Age: 58 YR
• Patient Sex: Female