MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; Implantable Lead

Model Number	4087
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776); Headache (1880); Syncope/Fainting (4411)
Date of Event	05/01/2024
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 detective.
Event or Problem Description
It was reported that during a follow up visit, the patient had presented with chest pain, headache and a right ventricular (rv) lead fracture.The pacemaker was noted to have reached eol in 2023.One month later, the patient experienced a syncopal episode, and a device interrogation confirmed the rv lead fracture.The physician elected not to replace the pacemaker and instead place an implantable loop recorder (ilr) to assess the need for pacing.This rv lead remains in service and no adverse patient effects have been reported.
Event or Problem Description
It was reported that during a follow up visit, the patient had presented with chest pain, headache and a right ventricular (rv) lead fracture.The pacemaker was noted to have reached eol in 2023.One month later, the patient experienced a syncopal episode, and a device interrogation confirmed the rv lead fracture.The physician elected not to replace the pacemaker and instead place an implantable loop recorder (ilr) to assess the need for pacing.This rv lead remains in service and no adverse patient effects have been reported.
Additional Manufacturer Narrative
Correction to field bsc aware date.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 detective.

• 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): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25480720
• Report Number: 2124215-2026-31450
• Device Sequence Number: 13342866
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: (01)00802526397738(17)111203
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2026

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: 12/03/2011
• Device Model Number: 4087
• Device Catalogue Number: 4087
• Device Lot Number: 292409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 05/15/2026; 08/14/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 06/12/2026; 08/18/2026
• Date Device Manufactured: 12/03/2009
• 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
• Patient Age: 45 YR
• Patient Sex: Female