MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 45 MODEL 4135 US 644135-102; PACING LEAD

Model Number 358744

Device Problems Pacing Intermittently (1443); Ambient Noise Problem (2877)

Patient Problems Dizziness (2194); Syncope/Fainting (4411)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Boston scientific provided the following information: on (b)(6) 2024 simultaneous non-physiologic noise was seen on both a & v leads.The patient was contacted and reported dizziness and syncope.On (b)(6) at in-person visit, arm movements reproduced noise and inhibited pacing in both leads.Patient was admitted to the hospital.On (b)(6) a new system implanted on the right and the old system on left was turned off and abandoned.This lead was capped.Should additional information be received, this file will be updated.

Manufacturer Narrative

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

• Brand Name: DEXTRUS 45 MODEL 4135 US 644135-102
• Type of Device: PACING LEAD
• 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: 18890313
• MDR Text Key: 337558047
• Report Number: 1028232-2024-01380
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P950037
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 358744
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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