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

Model Number	4087
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product remains implanted and in-service; 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 known inherent risk of device.
Event or Problem Description
It was reported that the communicator for the patient with this pacemaker and right ventricular (rv) lead exhibited a red call doctor alert.At this time, the cause for the alert remains unknown.This pacemaker and rv lead remain in service.No adverse patient effects were reported.Additional information received from the field confirmed that this pacemaker and right ventricular (rv) lead exhibited pacing impedance measurements that were high and out of range.The local company representative contacted the patient to arrange a device check as soon as possible; however, the patient has not responded at this time.No 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: 25673627
• Report Number: 2124215-2026-35044
• Device Sequence Number: 10407270
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: (01)00802526397738(17)100624
• 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: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 06/24/2010
• Device Model Number: 4087
• Device Catalogue Number: 4087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 06/24/2008
• 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