MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 VR-T DX DF4 PROMRI; ICD

Model Number 429525

Device Problem Vibration (1674)

Patient Problem Burning Sensation (2146)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Patient reported feeling vibrating and a burning sensation at the implant site.Patient was informed that our devices do not vibrate for alerts and directed them to their physician for further discussion.Device remains implanted.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: ACTICOR 7 VR-T DX 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: 16375569
• MDR Text Key: 309528735
• Report Number: 1028232-2023-00809
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 04035479156701
• UDI-Public: (01)04035479156701(17)230630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 429525
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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 Age: 74 YR
• Patient Sex: Female