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

Model Number	429568
Medical Device Problem Codes	Failure to Capture (1081); Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently not available for analysis.A conclusion with regard to clinical observation cannot be made at present.No supplementary data are available and further data is not expected to be obtained.The case is thus closed.Should additional information come in at a later time, the case will be reopened and the investigation continued.
Event or Problem Description
It was reported, that approximately 15 days after implantation time, appropriate but ineffective shocks were delivered by the implanted icd and an external shock was delivered by the emergency doctor.The device could no longer be queried and is functionally ineffective (no more ventricular stimulation in the case of (b)(6)).On (b)(6) 2020 the icd delivered multiple shocks, but these were not effective.The emergency doctor found ventricular fibrillation and shocked the patient externally several times.This enabled the patient to be brought into a normal-frequency heart rhythm.The patient was admitted to the (b)(6) hospital and given an ecmo due to his poor condition.Later the patient was transferred to another hospital and remains in the intensive care unit.

• 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 ; DE 12359
• MDR Report Key: 10996472
• Report Number: 1028232-2020-05475
• Device Sequence Number: 3737727
• Product Code: MRM
• UDI-Device Identifier: 04035479156947
• UDI-Public: 04035479156947
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P000009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 429568
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/12/2020
• 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