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

Model Number	401658
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Migration was reported on this device.Device moves up into the collarbone and down to the axilla.Patient reported discomfort and tenderness at the device site.No surgical intervention was reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.A review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the device was mechanically as expected.The root cause for the observed device migration could not be determined.

• Brand Name: IPERIA 7 HF-T QP DF4 IS4
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8813984
• Report Number: 1028232-2019-03035
• Device Sequence Number: 16836345
• Product Code: NIK
• UDI-Device Identifier: 04035479138721
• UDI-Public: 04035479138721
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 401658
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR