MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 5 DR-T DF-1 PROMRI; ICD

Model Number	429568
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
After an implantation period of approx.10 months, an asystole was observed.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the existing production documents, as well as the returned device data.The manufacturing process of this device was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior.The available device data were analyzed.The analysis showed no indications of a device malfunction.In summary, the device shows no anomalies in regard to the manufacturing process and the provided device data.Based on the available information, there was no indication of a device malfunction.

• Brand Name: INTICA NEO 5 DR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10758808
• Report Number: 1028232-2020-04707
• Device Sequence Number: 11047504
• Product Code: MRM
• UDI-Device Identifier: 04035479156947
• UDI-Public: 04035479156947
• Combination Product (Y/N): N
• PMA/510(K) Number: P000009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 08/31/2021
• Device Model Number: 429568
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization