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

Model Number 429553

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

This device was explanted due to eri, possibly from high threshold on the lv lead.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

The device was returned and analyzed.The device memory demonstrated a normal device function while the device was implanted and in service.The inspection of the device memory revealed that an elevated current was used for anti-bradycardia pacing.This indicates that high output was programmed that resulted in a faster discharge of the battery.The bench test of the icd revealed that all therapy functions were available, especially the current used for anti-bradycardia pacing was normal.In conclusion, the device was fully functional.There was no indication of a device malfunction.Analysis of the device revealed a normal battery depletion.

• Brand Name: INTICA NEO 7 HF-T DF-1 IS-1 PROMRI
• Type of Device: 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: 16387326
• MDR Text Key: 309745938
• Report Number: 1028232-2023-00864
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156831
• UDI-Public: (01)04035479156831(17)220731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

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 Expiration Date: 07/31/2022
• Device Model Number: 429553
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 06/21/2023
• Supplement Dates FDA Received: 02/20/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female