MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 7 HF-T QP DF-1 IS4 PROMRI; CRT-D

Model Number	429552
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted because it could not be interrogated following external shock during an ablation.Should additional information be received, this file will be updated.
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.
Additional Manufacturer Narrative
Upon receipt, the device could not be interrogated, confirming the clinical observation.Therefore, the device was opened to inspect the inner assembly and to check the functionality of the electronic module.Analysis of the electronic module revealed that the output stage of one high voltage circuit and several other electric components had been damaged.These damages led to an elevated current consumption, which depleted the battery.Due to this and the damages of the electronic module the device could not be interrogated properly.Based on the damage symptoms of the electronic module, the damages were most probably caused by the reported external defibrillation.In general the icd is protected against the high voltage discharge during an external defibrillation, but depending on the position of the external defibrillation electrodes and individual patient circumstances a damage of the electronic module cannot be excluded.At a next step, the manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the observed damage characteristics.Particularly the final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.

• Brand Name: INTICA NEO 7 HF-T QP DF-1 IS4 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: 18450373
• Report Number: 1028232-2024-00056
• Device Sequence Number: 7660858
• Product Code: NIK
• UDI-Device Identifier: 04035479156824
• UDI-Public: (01)04035479156824(17)241231
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2024

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: 12/31/2024
• Device Model Number: 429552
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/05/2024; 05/16/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/09/2024; 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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: 71 YR
• Patient Sex: Male