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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from disorder of consciousness, motor restlessness but did not move the left limbs, momentum gradually appeared.Transient ischemic attack was given as the cardiovascular cause.Patient was hospitalized and brain ct was done for diagnostics.No device involvement was reported.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.

• 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 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14361790
• Report Number: 1028232-2022-02435
• Device Sequence Number: 17182453
• Product Code: NIK
• UDI-Device Identifier: 04035479156824
• UDI-Public: 04035479156824
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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: 01/31/2024
• Device Model Number: 429552
• Device Catalogue Number: SEE MODEL NO.
• 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: 05/05/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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 Sex: Unknown