MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 53 MODEL 4136 US 644136-102; PACING LEAD

Model Number	358754
Medical Device Problem Code	Unstable Capture Threshold (3269)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Boston scientific provided the following information: possible capture issues were reported on this lead.The patient experienced syncope.The lead remains actively implanted.

• Brand Name: DEXTRUS 53 MODEL 4136 US 644136-102
• Common Device Name: 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: 15100288
• Report Number: 1028232-2022-03764
• Device Sequence Number: 14812027
• Product Code: NVN
• UDI-Device Identifier: 04035479143213
• UDI-Public: 04035479143213
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 358754
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown