MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 DR-T DF4 PROMRI; ICD

Model Number 429534

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problems Tachycardia (2095); Shock from Patient Lead(s) (3162)

Event Date 05/28/2023

Event Type  Injury  

Event Description

It was reported that noise most likely originating from an external source led to atp therapy resulting in a ventricular tachycardia which was treated with a shock.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.Upon inspection of the available iegms the clinical observation was confirmed.Based on the data, the clinical observation resulted from an external noise source.There is no indication of an icd malfunction.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of an icd malfunction.

• Brand Name: RIVACOR 7 DR-T DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17162709
• MDR Text Key: 317471652
• Report Number: 1028232-2023-03083
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 429534
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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