MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 60 MODEL 4137 US 644137-102; PACING LEAD

Model Number 358764

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Intermittently (1443)

Patient Problem Dizziness (2194)

Event Date 08/30/2022

Event Type  malfunction  

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.

Event Description

Boston scientific provided the following information: patient experiencing lightheadedness during periods of oversensing, loss of capture and pacing inhibition lasting 3-4 seconds.Further lead evaluation was suggested.Lead remains implanted at this time.Should additional information be received, this file will be updated.

• Brand Name: DEXTRUS 60 MODEL 4137 US 644137-102
• 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: 15601615
• MDR Text Key: 301763334
• Report Number: 1028232-2022-05272
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: 358764
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2011
• 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