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

Model Number 429553

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

This device was explanted due to eri.Patient is very sick and has had over 100 shocks due to vt/vf.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the eri battery status, a number of 173 charging cycles with multiple shock deliveries was recorded to the devices memory.The amount of charge taken from the battery was verified.The battery condition was found to be normal and as expected.In a next step the memory content of the device was inspected.The inspection, especially of the available iegms, revealed a normal and expected device behavior.There was no indication of a device malfunction.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the icd was fully functional.The eri battery status was as expected.

• Brand Name: INTICA NEO 7 HF-T DF-1 IS-1 PROMRI
• Type of Device: 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: 16383007
• MDR Text Key: 309643393
• Report Number: 1028232-2023-00836
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156831
• UDI-Public: (01)04035479156831(17)221130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 429553
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male