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 Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This device shows eri with unexpected battery behavior.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The icd 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 data.The manufacturing process for this device was re-investigated.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 data have been analyzed.The inspection revealed that the icd activated the eri status, because during an automatic signature check the device detected invalid memory content in the life-holter, a memory range containing battery data.In general, the icd is equipped with the ability to detect and repair invalid memory content.If there was invalid memory content found in the life-holter, by design the icd will activate the device status eri to avoid an incorrect automatic longevity calculation.This does not represent a device malfunction.The ability of the device to deliver therapies is not affected by this safety mechanism.We would like to recommend to replace the device and to return it for analysis to biotronik.Of course, individual circumstances and medical judgment determine decisions about patient care and the frequency of follow-up sessions.The above recommendation is based on a purely technical assessment.Should further relevant information or the device itself become available this investigation will be updated.
Additional Manufacturer Narrative
The device was explanted on (b)(6) 2026.The icd 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 data.The manufacturing process for this device was re-investigated.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 data have been analyzed.The inspection revealed that the icd activated the eri status, because during an automatic signature check the device detected invalid memory content in the life-holter, a memory range containing battery data.In general, the icd is equipped with the ability to detect and repair invalid memory content.If there was invalid memory content found in the life-holter, by design the icd will activate the device status eri to avoid an incorrect automatic longevity calculation.This does not represent a device malfunction.The ability of the device to deliver therapies is not affected by this safety mechanism.We would like to recommend to replace the device and to return it for analysis to biotronik.Of course, individual circumstances and medical judgment determine decisions about patient care and the frequency of follow-up sessions.The above recommendation is based on a purely technical assessment.Should further relevant information or the device itself become available this investigation 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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24495661
• Report Number: 1028232-2026-01079
• Device Sequence Number: 10684813
• Product Code: NIK
• UDI-Device Identifier: 04035479156831
• UDI-Public: (01)04035479156831(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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: 02/28/2026
• Device Model Number: 429553
• Device Catalogue Number: 429553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 03/18/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Female