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

Model Number	0174
Medical Device Problem Codes	High impedance (1291); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedance measurements.Technical services (ts) was consulted, discussed sudden out of range measurements and normal sensing.Ts discussed possible conductor fracture and recommended performing a vector breakdown and discuss possible reprogramming options.This rv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedance measurements.Technical services (ts) was consulted, discussed sudden out of range measurements and normal sensing.Ts discussed possible conductor fracture and recommended performing a vector breakdown and discuss possible reprogramming options.This rv lead remains in service.No adverse patient effects were reported.Additional information was received, this right ventricular (rv) lead was explanted and successfully replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual inspection confirmed that the lead was returned in two segments severed approximately 137mm from the terminal end.Resistance testing found that the lead was not electrically continuous.Detailed analysis confirmed that residual calcification was noted on the tip.Insulation damaged was observed at approximately 360mm and 435mm from the tip, characteristics of the insulation damage are consistent with lead on lead abrasion.A fractured proximal shocking conductor was observed at approximately 255 mm from the tip.Analysis concluded that based on the characteristics of the fracture, it was determined that it was consistent with cyclic fatigue damage.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.A risk review was completed and confirmed that the event of shock impedance high out of range was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on a thorough review of the reported complaint, the conclusion code cause traced to device design.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedance measurements.Technical services (ts) was consulted, discussed sudden out of range measurements and normal sensing.Ts discussed possible conductor fracture and recommended performing a vector breakdown and discuss possible reprogramming options.This rv lead remains in service.No adverse patient effects were reported.Additional information was received, this right ventricular (rv) lead was explanted and successfully replaced.No additional adverse patient effects were reported.

• 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 ; 6515826168
• MDR Report Key: 23405751
• Report Number: 2124215-2025-77372
• Device Sequence Number: 12003919
• Product Code: LWS
• UDI-Device Identifier: 00802526373640
• UDI-Public: (01)00802526373640(17)050617
• Combination Product (Y/N): N
• 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: 2004
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/17/2026

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: 06/17/2005
• Device Model Number: 0174
• Device Catalogue Number: 0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 04/15/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/05/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2003
• 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: 73 YR
• Patient Sex: Male