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

Model Number 393009

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 12/05/2019

Event Type  malfunction  

Event Description

This device was explanted and replaced due to eri.The device was programmed at max output for over a year due to a myopore lv lead with high thresholds - 7.5v at 1.5ms at the time of explant.Lead had steadily increasing thresholds over the last year.Lv lead was explanted and replaced as well.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.The device is currently not available for analysis.Therefore, no conclusion can be drawn at this time.However, biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.Should additional relevant information become available, this investigation will be updated.

• Brand Name: IPERIA 7 HF-T DF4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9531415
• MDR Text Key: 173095805
• Report Number: 1028232-2019-05782
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479129255
• UDI-Public: 04035479129255
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 393009
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR