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

Model Number	401662
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Device explanted due to migration causing the patient pain.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
The device was received and visually inspected.The device was normal and as expected.There was no indication of a deviation from the mechanical specification.A review of biotroniks post market surveillance database did not reveal any trend for this type of event.In conclusion, the device was mechanically as expected.The root cause for the observed device migration could not be determined.

• 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: 12589465
• Report Number: 1028232-2021-05499
• Device Sequence Number: 11877228
• 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: 2017
• 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): 09/14/2021

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: 06/30/2018
• Device Model Number: 401662
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female