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

Model Number	4086
Medical Device Problem Codes	Signal Artifact/Noise (1036); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: with the available information, boston scientific concluded the clinical observation of high capture threshold is a known inherent risk of the device and is noted within the product's instructions for use (ifu), as well as the product's risk documentation.Device technical analysis: this lead remains implanted.As such, physical analysis has not been conducted in our laboratory.
Event or Problem Description
It was reported that the healthcare provider wanted assistance in programming the pacemaker for magnetic resonance imaging (mri).Review of the device system demonstrated noise on the atrial lead, along with a high threshold (5.0 v at 0.4 ms).Technical services discussed that the pacemaker system was no longer mri conditional due to the non-functioning atrial lead and advised obtaining a new cardiology order.The atrial lead remains implanted.

• 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: 24789601
• Report Number: 2124215-2026-18494
• Device Sequence Number: 8805717
• Product Code: DTB
• UDI-Device Identifier: 00802526397721
• UDI-Public: (01)00802526397721(17)070228
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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
• Report Date (Section B): 04/06/2026

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: 02/28/2007
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 02/28/2005
• 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 Sex: Male