MAUDE Adverse Event Report: BIOTRONIK SE & CO .KG DEXTRUS; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	4135
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was surgically abandoned due to poor sensing.Another ra lead was successfully placed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Additional Manufacturer Narrative
Correction: dextrus is not a bsc product.
Event or Problem Description
It was reported that this right atrial (ra) lead was surgically abandoned due to poor sensing.Another ra lead was successfully placed.No additional adverse patient effects were reported.

• Brand Name: DEXTRUS
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK SE & CO .KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23645760
• Report Number: 2124215-2025-86403
• Device Sequence Number: 10122798
• Product Code: NVZ
• UDI-Device Identifier: 04035479143206
• UDI-Public: (01)04035479143206
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P950037/S048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 4135
• Device Catalogue Number: 4135
• Device Lot Number: 29539492
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female