MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; Implantable Cardioverter Defibrillator (ICD)

Model Number	4087
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a product performance issue and was abandoned.The patient underwent a surgical intervention to implant a new lead with a pacemaker on the right side of their chest.No additional adverse patient effects were reported.\ \ additional information was received that this rv lead exhibited noisy signals, this were oversensed and pacing inhibition was noted.No additional adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a product performance issue and was abandoned.The patient underwent a surgical intervention to implant a new lead with a pacemaker on the right side of their chest.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was requested.This investigation will be updated should further information be provided.

• Brand Name: FLEXTEND
• Common Device Name: Implantable Cardioverter Defibrillator (ICD)
• 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: 50090912
• Report Number: 2124215-2026-41072
• Device Sequence Number: 21286195
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: (01)00802526397738(17)070531
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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: 05/31/2007
• Device Model Number: 4087
• Device Catalogue Number: 4087
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 05/31/2005
• 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: 89 YR
• Patient Sex: Female