MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 7 HF-T QP DF-1 IS4 PROMRI; CRT-D

Model Number 404629

Device Problem Pacemaker Found in Back-Up Mode (1440)

Patient Problem Implant Pain (4561)

Event Date 08/15/2022

Event Type  malfunction  

Event Description

This device triggered backup mode on (b)(6) 2022.The device was successfully reinitialized.The patient reported strong pain at the implant site around the time of backup mode being triggered.The pain was still present when the patient was seen in the clinic, but had lessened.The pain went away all together after re-initialization.Device remains implanted.

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: INTICA 7 HF-T QP DF-1 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15265885
• MDR Text Key: 298316545
• Report Number: 1028232-2022-04254
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479142162
• UDI-Public: (01)04035479142162(17)200131
• 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,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 404629
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2018
• 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: 82 YR
• Patient Sex: Male