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

Model Number	0180
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range pacing impedance measurements.Noise on the presenting and stored electrograms (egms) was also noted.Inappropriate anti-tachycardia pacing (atp) due to noise oversensing was determined.Rv lead replacement was recommended.Currently, this product remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range pacing impedance measurements.Noise on the presenting and stored electrograms (egms) was also noted.Inappropriate anti-tachycardia pacing (atp) due to noise oversensing was determined.Rv lead replacement was recommended.Subsequently, a revision procedure was performed and the rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Explant performed.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23924137
• Report Number: 2124215-2025-93723
• Device Sequence Number: 9012789
• Product Code: LWS
• UDI-Device Identifier: 00802526531149
• UDI-Public: (01)00802526531149(17)160519
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 05/19/2016
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Device Lot Number: 310882
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 05/19/2014
• 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: Female