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

Model Number	4088
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported this right ventricular (rv) lead exhibited noise.Technical services (ts) reviewed that the rv lead impedance was at 450-1800 ohms and has lead integrity anomaly.This lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported this right ventricular (rv) lead exhibited noise.Technical services (ts) reviewed that the rv lead impedance was at 450-1800 ohms and has lead integrity anomaly.This lead remains in service.No adverse patient effects were reported.Additional information indicated that the source of noise was undetermined.Also, the noise was oversensing but this did not inhibit any function as the patient was pacing in the atrium and ventricle at 0%.The physician planned to continue monitoring the patient due to low pacing percentages.There was no immediate need for lead revision at this time.

• 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: 24049972
• Report Number: 2124215-2026-02067
• Device Sequence Number: 9856246
• Product Code: DTB
• UDI-Device Identifier: 00802526397745
• UDI-Public: (01)00802526397745(17)070513
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 05/13/2007
• Device Model Number: 4088
• Device Catalogue Number: 4088
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 05/13/2005
• 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 Age: 72 YR
• Patient Sex: Male