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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	11/22/2023
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2023, the patient had a few non-sustained tachycardia episodes as well as one therapy zone episode that was classified as an svt (no therapy provided by device) while the episode showed what appeared to be a true vt where therapy was desired.The device appears to have performed according to the programming given the therapy zones cutoffs and smart detection in dx devices with the onset and stability values of the presenting rhythm.The patient was reported to have passed away after these episodes at an unknown date and time.
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 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 device functions to be as specified.The returned follow-up data from november 22nd, 2023, have been analyzed.A total of 6 episodes were documented.Analysis showed that episode nr.2 from november 22nd, 2023, from 14:53 h until 14:54 h was detected correctly as svt by the icd, because the stability criterium was not met.Analysis showed that the icd functioned as specified according to the programmed parameters and heart rhythm of this patient.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 a normal and expected icd behavior.

• 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: 18271952
• Report Number: 1028232-2023-06176
• Device Sequence Number: 4006644
• Product Code: LWS
• UDI-Device Identifier: 04035479156855
• UDI-Public: (01)04035479156855(17)250930
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 429559
• Device Catalogue Number: 429559
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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: Death
• Patient Age: 68 YR
• Patient Sex: Female