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

Model Number	4087
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 this pacemaker system, with this right ventricular (rv) lead, had been failing to measure this rv lead threshold due a to a low evoked response at the automatic threshold test.Technical services (ts) noted a high capture threshold and recommended retesting the threshold manually and setting a fixed output.Ts assisted with reprogramming the device to incorporate an appropriate safety margin.Isometric exercises were subsequently performed to rule out any loss of capture (loc) or artifact.Prior to reprogramming, ts had observed intermittent loc.The health care professional (hcp) then indicated that they will follow up with electrophysiology taking into account the battery longevity and acknowledging the safety margin precedence.No adverse patient effects were reported.This rv lead remains in service.

• 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 ; +1(651)582-6168
• MDR Report Key: 25280422
• Report Number: 2124215-2026-28116
• Device Sequence Number: 9766365
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: (01)00802526397738(17)070426
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: 04/26/2007
• Device Model Number: 4087
• Device Catalogue Number: 4087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 04/26/2005
• 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: 80 YR
• Patient Sex: Female