MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Bi IS-1 Epi R/S; Permanent Pacemaker Electrode

Model Number	4056
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Loss of consciousness (2418); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction

• Brand Name: Bi IS-1 Epi R/S
• Common Device Name: Permanent Pacemaker Electrode
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Oscor/Intermedics; 2300 berkshire ln n; minneapolis MN 55441
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50151164
• Report Number: 2124215-2026-42099
• Device Sequence Number: 9103257
• Product Code: DTB
• UDI-Device Identifier: 00821329900211
• UDI-Public: (01)00821329900211(11)250701(17)280701
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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 Model Number: 4056
• Device Catalogue Number: 4056
• Device Lot Number: 355664
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 07/01/2025
• 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; Hospitalization
• Patient Sex: Unknown