MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; PERMANENT PACEMAKER ELECTRODE

Model Number	4088
Medical Device Problem Codes	Over-Sensing (1438); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this pacemaker system exhibited right ventricular (rv) lead oversensing.The patient was in atrial fibrillation/flutter.Additionally, electrogram (egm) review showed right ventricular (rv) lead signals lined up with the right atrial (ra) channel, with larger discreet rv signals that were likely true rv events.Rv sensitivity was programmed to 5mv in june or july 2018.Similar oversensing was also observed in may 2018, shortly after implant.There was no indication of pacing pauses greater than two seconds, and the patient's intrinsic rhythm was observed frequently enough.Review of daily measurements noted r-waves below below 2-3 mv.Additional information received eight years later reported that this pacemaker system stored additional ventricular events containing oversensing.

• 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): 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: 24565326
• Report Number: 2124215-2026-13379
• Device Sequence Number: 20921626
• Product Code: DTB
• UDI-Device Identifier: 00802526397745
• UDI-Public: (01)00802526397745(17)100806
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: 08/06/2010
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 08/06/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female