MAUDE Adverse Event Report: BIOTRONIK SE & CO .KG DEXTRUS; IMPLANTABLE LEAD

Model Number	4135
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was capped and surgically abandoned due to it presenting undersensing issues, with the issue traced back to the lead by examining the lead by pacing system analyzer (psa).A new device was implanted.No additional patient effects were reported.
Additional Manufacturer Narrative
This event is no longer reportable since boston scientific does not own mdr reporting obligations for this product.
Event or Problem Description
It was reported that this right atrial (ra) lead was capped and surgically abandoned due to it presenting undersensing issues, with the issue traced back to the lead by examining the lead by pacing system analyzer (psa).A new device was implanted.No additional patient effects were reported.

• Brand Name: DEXTRUS
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO .KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer (Section G): BOSTON SCIENTIFIC; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16904098
• Report Number: 2124215-2023-23033
• Device Sequence Number: 5561552
• Product Code: NVZ
• UDI-Device Identifier: 04035479143206
• UDI-Public: 04035479143206
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P950037/S048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 05/15/2023

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: 11/30/2015
• Device Model Number: 4135
• Device Catalogue Number: 4135
• Device Lot Number: 29346633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Female