MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; IMPLANTABLE LEAD

Model Number	4086
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited low pacing impedance out of range (oor) measurements on the right atrial (ra) lead, which triggered to lead safety switch (lss) from bipolar to unipolar mode.Inappropriate atrial tachy response (atr)s due to noise was also observed prior and post lss.It was confirmed that this ra lead has an insulation breach.Further evaluation was recommended.Currently, this product remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited low pacing impedance out of range (oor) measurements on the right atrial (ra) lead, which triggered to lead safety switch (lss) from bipolar to unipolar mode.Inappropriate atrial tachy response (atr)s due to noise was also observed prior and post lss.It was confirmed that this ra lead has an insulation breach.Further evaluation was recommended.Currently, this product remains in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.The "known inherent risk of device" conclusion code was selected because this is well known old lead.Damage occurring to old leads are not unexpected and can result from multiple causes.In addition, the complaint device was not returned to bsc - product analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of damaged/defective was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Since the reported issues are covered by the instructions for use, it can be concluded that expected or well-understood factors most probably contributed to the event.

• Brand Name: FLEXTEND
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646 ; CS 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24252887
• Report Number: 2124215-2026-06210
• Device Sequence Number: 8346233
• Product Code: DTB
• UDI-Device Identifier: 00802526397721
• UDI-Public: (01)00802526397721(17)070405
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/05/2007
• Device Model Number: 4086
• Device Catalogue Number: 4086
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/06/2026
• Date Device Manufactured: 04/05/2005
• 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
• Patient Age: 55 YR
• Patient Sex: Male