MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT?; Implantable Lead

Model Number	0676
Medical Device Problem Codes	Failure to Read Input Signal (1581); Low impedance (2285); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The lead 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.
Event or Problem Description
It was reported that this recently implanted right ventricular (rv) lead exhibited low intrinsic amplitude and an elevated capture threshold.Additionally, the pace and shock impedance measurements were low and within normal limits.Technical services (ts) was consulted and reviewed data, determining the change in daily measurements indicated a possible lead dislodgement which was confirmed by the local field representative through an x ray.The lead was subsequently explanted and replaced; however, the lead was damaged during the procedure and discarded.No additional adverse effects were reported.This rv lead is no longer in service.
Event or Problem Description
It was reported that this recently implanted right ventricular (rv) lead exhibited low intrinsic amplitude and an elevated capture threshold.Additionally, the pace and shock impedance measurements were low and within normal limits.Technical services (ts) was consulted and reviewed data, determining the change in daily measurements indicated a possible lead dislodgement which was confirmed by the local field representative through an x ray.The lead was subsequently explanted and replaced; however, the lead was damaged during the procedure and discarded.No additional adverse effects were reported.This rv lead is no longer in service.
Additional Manufacturer Narrative
The lead was not returned for analysis; therefore, a technical analysis could not be performed.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.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.A risk review was completed and confirmed that the event of dislodged or dislocated 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.A similar complaint review was completed using global similar complaint review tool, which reviewed as reported device code 1414: dislodged or dislocated and did not identify any emerging trends or similar complaints that require escalation.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: RELIANCE 4-FRONT?
• 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: 25892984
• Report Number: 2124215-2026-39205
• Device Sequence Number: 18646359
• Product Code: NVY
• UDI-Device Identifier: 00802526497001
• UDI-Public: (01)00802526497001(17)260828
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 08/28/2026
• Device Model Number: 0676
• Device Catalogue Number: 0676
• Device Lot Number: 519252
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 08/28/2024
• 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: 82 YR
• Patient Sex: Male