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

Model Number	4087
Medical Device Problem Codes	Insufficient Device Problem Information (3190); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that this right ventricular (rv) lead was surgically abandoned due to a non specific product performance allegation.A new rv septum lead was implanted at the same procedure.The pacemaker was explanted due to normal battery depletion (nbd) after several years of being implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that this right ventricular (rv) lead was surgically abandoned due to high rv pacing threshold.No loss of capture or patient symptoms.A new rv septum lead was implanted at the same procedure.The pacemaker was explanted due to normal battery depletion (nbd) after several years of being implanted.No additional adverse patient effects were reported.

• 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
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25226488
• Report Number: 2124215-2026-27125
• Device Sequence Number: 18594477
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: (01)00802526397738(17)070608
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 06/08/2007
• Device Model Number: 4087
• Device Catalogue Number: 4087
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 06/08/2005
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female