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

Model Number	429559
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.The inspection of the available iegms confirmed that noise detection in the atrial channel led to at recordings at 1-hour intervals.Despite thorough analysis, the root cause of the noise signals was not determinable.However, it cannot be excluded that a potential change of the lead position might have led to this occurrence.The analysis did not show any indication of an icd malfunction.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of an icd malfunction.A change in the lead position cannot be excluded.
Event or Problem Description
Clinician reports the device records recurrent 5 minute episodes of noise on the atrial channel as at recordings at exact 1 hour intervals and states they have ruled out all possible sources of emi.Clinician believes this is an issue with the device and not environmental.Ram download attached.Device remains implanted.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: 21405699
• Report Number: 1028232-2025-00813
• Device Sequence Number: 15526622
• Product Code: LWS
• UDI-Device Identifier: 04035479156855
• UDI-Public: (01)04035479156855(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 02/13/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Male