MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; Implantable Lead

Model Number	0174
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a high shock impedance values.The patient underwent a surgical intervention to remove the lead and implant a new device with leads successfully.No additional adverse patient effects were reported.Additional information was received that this rv lead exhibited areas of calcification that were observed during the revision procedure.No additional adverse patient effects were reported outside the revision procedure.

• Brand Name: ENDOTAK RELIANCE G
• 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 ; +1(651)582-6168
• MDR Report Key: 25829108
• Report Number: 2124215-2026-37996
• Device Sequence Number: 9711629
• Product Code: LWS
• UDI-Device Identifier: 00802526373640
• UDI-Public: (01)00802526373640(17)070420
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2026

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: 04/20/2007
• Device Model Number: 0174
• Device Catalogue Number: 0174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 04/20/2005
• 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: 64 YR
• Patient Sex: Male