MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; Permanent Pacemaker Electrode

Model Number	4086
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient with this right atrial (ra) lead had exhibited infection and subsequently died.A revision was performed and the lv lead, along with the right ventricular (rv) lead and ra lead were explanted.No additional adverse patient effects were reported.This ra lead was not returned for analysis.No further information was provided.
Event or Problem Description
It was reported that the patient with this right atrial (ra) lead had exhibited infection and subsequently died.A revision was performed and the lv lead, along with the right ventricular (rv) lead and ra lead were explanted.No additional adverse patient effects were reported.This ra lead was not returned for analysis.No further information was provided.
Additional Manufacturer Narrative
Investigation summary: with all available information, boston scientific concludes that unknown factors most probably contributed to the event.If the product is returned to boston scientific for analysis, a report will be provided.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: the complaint device was not returned to boston scientific as it has not been returned for investigation, so product analysis could not be performed.Product record reviews did not identify a potential product quality issue or new patient harm.Labeling review: review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Risk review: a risk review was completed and confirmed that the event of infection was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: it can be concluded that unknown factors most probably contributed to the event.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: FLEXTEND
• Common Device Name: Permanent Pacemaker Electrode
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24944614
• Report Number: 2124215-2026-21552
• Device Sequence Number: 18665140
• Product Code: DTB
• UDI-Device Identifier: 00802526397721
• UDI-Public: (01)00802526397721(17)131017
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/17/2013
• Device Model Number: 4086
• Device Catalogue Number: 4086
• Device Lot Number: 260570
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 10/17/2011
• 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; Death; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female