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

Model Number	4088
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow up visit, this right ventricular (rv) lead was believed to have fractured due to exhibited high out of range impedances, oversensing noise and high thresholds.A revision procedure was performed where this rv lead was explanted and replaced with a new lead successfully.No additional adverse patient effects were reported.This rv lead was retained by the hospital.
Event or Problem Description
It was reported that during a follow up visit, this right ventricular (rv) lead was believed to have fractured due to exhibited high out of range impedances, oversensing noise and high thresholds.A revision procedure was performed where this rv lead was explanted and replaced with a new lead successfully.No additional adverse patient effects were reported.This rv lead was retained by the hospital.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Device history: 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.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 assessment: a risk review was completed and confirmed that the event of fracture 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: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 24538152
• Report Number: 2124215-2026-12722
• Device Sequence Number: 10372366
• Product Code: DTB
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 05/02/2007
• Device Model Number: 4088
• Device Catalogue Number: 4088
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 05/02/2005
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male