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

Model Number	4087
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a clinic visit, chest xray images showed this right ventricular (rv) lead was found to have need surgically abandoned and was curled up next to the device.No additional adverse patient effects were reported.At this time, no additional information was provided.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
This report is being submitted to correct the serial number(d4), implant date(d6a) in section d, suspect medical device an amendment report is being filed to correct the lead model serial number as subsequent review and additional information indicates the lead on the previous report remains in service and the corrected lead was previously processed.This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that during a clinic visit, chest xray images showed this right ventricular (rv) lead was found to have need surgically abandoned and was curled up next to the device.No additional adverse patient effects were reported.At this time, no additional information was provided.

• 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: 24983049
• Report Number: 2124215-2026-22333
• Device Sequence Number: 9698937
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: (01)00802526397738(17)051031
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 04/27/2026

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: 10/31/2005
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 10/31/2003
• 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 Sex: Male