MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 7 VR-T DX DF-1 PROMRI; ICD

Model Number	429559
Medical Device Problem Codes	High impedance (1291); Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
This device had an alert for greater than 150 shock impedance at implant follow-up.A pin connecter/header issue was suspected.At (b)(6) 2025 revision procedure, they found the df1 connector pin leg was loose in pocket.This was reconnected and all testing normal.No adverse patient events were reported.Should additional information be received, this file will be updated.

• Brand Name: INTICA NEO 7 VR-T DX DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21321386
• Report Number: 1028232-2025-00638
• Device Sequence Number: 7915122
• Product Code: LWS
• UDI-Device Identifier: 04035479156855
• UDI-Public: (01)04035479156855(17)261130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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 Model Number: 429559
• Device Catalogue Number: 429559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2024
• 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: 69 YR
• Patient Sex: Male