MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 HF-T DF4 IS-1 PROMRI; CRT-D

Model Number 429523

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Implant Pain (4561)

Event Date 02/26/2024

Event Type  Injury  

Event Description

Device and lbbap lead explanted due to patient complaint of discomfort and pain.A smaller device was implanted.Should additional information be received, this file will be updated.

• Brand Name: ACTICOR 7 HF-T DF4 IS-1 PROMRI
• Type of Device: CRT-D
• 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: 18851882
• MDR Text Key: 337067715
• Report Number: 1028232-2024-01237
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156688
• UDI-Public: (01)04035479156688(17)240831
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Model Number: 429523
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/06/2024
• Date Device Manufactured: 08/09/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Male