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

Model Number	0171
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product was manufactured before the implementation of the udi regulation, so the complete udi is unavailable.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited an out of range intrinsic amplitude outputs of 5.7 millivolts to 23.8 millivolts.The patient was seen in the office but was not able to reproduce the anomaly.The boston scientific technical services consultant noted that all other lead measurements were normal.As of this time, this rv lead remains in service.No adverse patient effects were reported.Additional information indicated that the involved right atrial lead exhibited non-physiological signals and large signal artifacts across all three electrogram channels.These signals originated on the right atrial lead, with some appearing to conduct to the right ventricular lead following the placement of a hemodialysis catheter.The ts consultant recommended performing a chest x-ray to send to ts and review whether the catheter is dangling into the right atrium.Furthermore, the dialysis catheter was observed to be positioned against the cardiac leads in the device pocket, raising concern for a possible lead fracture.This issue resulted in an out-of-range shock lead impedance alert and logged episodes of non-sustained ventricular arrhythmia.Ts noted that these episodes showed nonphysiological noise rather than a true heart arrhythmia, corresponding with an abrupt increase in electrical resistance across the right ventricular pacing (550 to 1800 ohms), shock lead integrity (80 to more than 200 ohms), and left ventricular pacing (500 to 1121 ohms) circuits.Due to the suspected lead fracture, ts recommended bringing the patient into the clinic for evaluation.

• 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; PR 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25707112
• Report Number: 2124215-2026-35845
• Device Sequence Number: 5094307
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: (01)00802526373374(17)120820
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2026

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: 08/20/2012
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 103183
• 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: 07/01/2026
• Supplement Date Received by Manufacturer: 07/09/2026; 08/06/2026; 08/06/2026
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 07/10/2026; 08/07/2026; 08/07/2026
• Date Device Manufactured: 08/20/2010
• 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
• Patient Age: 75 YR
• Patient Sex: Female