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	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to high lv lead impedances through device, then normal through psa after multiple attempts.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional 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.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 7 months and 6 charging cycles were recorded to the devices memory.The memory content of the device was inspected.The analysis revealed a documented left ventricular lead impedance of > 3000 ohm, confirming the clinical observation.Besides that, the memory content showed no anomalies.In a next step, 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 and the measured impedances were normal and as expected.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.A thorough analysis of the icd proved the device to be fully functional.There was no indication of an icd malfunction.

• 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: 16103761
• Report Number: 1028232-2023-00061
• Device Sequence Number: 18060675
• Product Code: NIK
• UDI-Device Identifier: 04035479156824
• UDI-Public: (01)04035479156824(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: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2023

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: 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: 01/04/2023
• Supplement Date Received by Manufacturer: 01/06/2023; 05/24/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/09/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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: 78 YR
• Patient Sex: Male