MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 3 HF-T DF4 IS-1 PROMRI; No Match

Model Number 429572

Device Problems Failure to Transmit Record (1521); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that the device stopped transmitting data in home monitoring after the patient underwent aortic valve replacement surgery on (b)(6) 2023.Recordings showed false episodes of vf on the day of surgery.It is noted that the therapies had not been turned off before surgery.The patient is no longer followed in home monitoring.Based on analysis results it was decided to report this event.

Manufacturer Narrative

The icd and the cm devices under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this icd as well as the analysis of the available data.The manufacturing process for the icd was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during manufacturing.The final acceptance test proved the icd functions to be as specified.The available data were evaluated, confirming the clinical observation.However, no peculiarities were observed regarding the functionality of both cm devices.Therefore, the icd data was further evaluated.The available iegms documented the presence of noise on november 7th, 2023, presumably caused by the surgery procedure.This led to 20 charging cycles, 3 of which resulted in shock deliveries, because the icd detection had not been deactivated before the surgery.Due to this occurrence, it cannot be excluded that the clinical observation might have resulted from a potential damage of the icd, caused by the aortic valve replacement procedure.However, the root cause is not determinable only based on data analysis.Should further relevant information become available, this report will be updated.

• Brand Name: RIVACOR 3 HF-T DF4 IS-1 PROMRI
• Type of Device: No Match
• 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: 19125055
• MDR Text Key: 340384728
• Report Number: 1028232-2024-02062
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 429572
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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