MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD

Model Number	0171
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in shock impedances.A revision procedure was performed.During the procedure, the physician noted the rv lead had calcified.The rv lead was explanted and replaced with a new lead successfully.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in shock impedances.A revision procedure was performed.During the procedure, the physician noted the rv lead had calcified.The rv lead was explanted and replaced with a new lead successfully.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product was explanted and was not returned.As such, physical analysis has not been conducted in our laboratory.Based on the thorough review of available information, and in the absence of a product return, the analysis of available information did not identify a specific complaint cause.Boston scientific has assigned an investigation conclusion code of cause not established.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided 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.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.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24189276
• Report Number: 2124215-2026-04646
• Device Sequence Number: 8065562
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: (01)00802526373374(17)201217
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 12/17/2020
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 104593
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 12/17/2018
• 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 Age: 63 YR
• Patient Sex: Male