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

Model Number	429553
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
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
Device was at normal battery level in june 2022, then in july 2022 it showed eos.Patient was in cambodia at the time and just recently returned to the us.He was unable to receive adequate medical care.A service code was seen but no other message.It is unsure what pacing outputs and percentages were and if they contributed to higher battery drain.Rv lead shows noise.No therapies reported.Device remains implanted.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Additional information received on 13-aug-2025.Device was explanted on (b)(6) 2024.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
Device was at normal battery level in (b)(6) 2022, then in (b)(6) 2022 it showed eos.Patient was in cambodia at the time and just recently returned to the us.He was unable to receive adequate medical care.A service code was seen but no other message.It is unsure what pacing outputs and percentages were and if they contributed to higher battery drain.Rv lead shows noise.No therapies reported.Device remains implanted.Should additional information become available, this file will be updated.

• Brand Name: INTICA NEO 7 HF-T DF-1 IS-1 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 18990415
• Report Number: 1028232-2024-01745
• Device Sequence Number: 2997459
• Product Code: NIK
• UDI-Device Identifier: 04035479156831
• UDI-Public: (01)04035479156831(17)220731
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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 Expiration Date: 07/31/2022
• Device Model Number: 429553
• Device Catalogue Number: 429553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 08/13/2025
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/03/2024; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2020
• 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: 86 YR
• Patient Sex: Male