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

Model Number	0295
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead is exhibiting highly variable and intermittently high threshold measurements as well as gradually rising pace impedance measurements that are within normal specification limits.Boston scientific technical services (ts) reviewed device electrograms and lead trend data.Ts indicated manual rv capture tests performed in the clinic were appropriate and noted it is odd that pacing output has been up to 7.5 volts to get capture at one point but have come back down.Ts stated this as well as the gradual increase in pace impedance measurement are less indicative of a lead fracture and more related to the lead-tissue interface.Ts also noted that since the patient was indicated to have frequent ablations, this could also be contributing to changes in the heart tissue near the lead helix.Ts indicated that the patient has nearly no stored episodes and nothing to suggest a lead fracture.Ts provided guidance to the physician that since there is good left ventricular capture, it seems reasonable to monitor the rv lead for now.The rv lead remains in-service.No patient symptoms or adverse patient effects were reported.Additional information was received that the pace impedance measurements continued to rise and became out of range.Additionally, a history of loss of capture was noted.Ts noted that the sensing and shock lead impedance measurements were still intact.No adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50871533
• Report Number: 2124215-2026-50713
• Device Sequence Number: 13434582
• Product Code: NVY
• UDI-Device Identifier: 00802526531262
• UDI-Public: (01)00802526531262(17)170630
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 06/30/2017
• Device Model Number: 0295
• Device Catalogue Number: 0295
• Device Lot Number: 344674
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 06/30/2015
• 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
• Patient Age: 55 YR
• Patient Sex: Female