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

Model Number	0285
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that upon review of boston scientific latitude remote monitoring system stored data, we identified evidence that this lead exhibited high shock impedance measurements of greater than 125 ohms.No adverse patient effects have been reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a retrospective review of device data it was identified that this right ventricular lead exhibited high out of range shock impedance measurements.No other information was provided.No adverse patient effects were reported.Additional information was received that this right ventricular (rv) lead was explanted.It is unknown if this rv lead will be returned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during a retrospective review of device data it was identified that this right ventricular lead exhibited high out of range shock impedance measurements.No other information was provided.No adverse patient effects were reported.Additional information was received that this right ventricular (rv) lead was explanted.It is unknown if this rv lead will be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific and physical analysis could not be conducted.Investigation of the available information/data determined that the observed gradual rise in low-voltage shock impedance (lvsi) measurements was likely associated with calcification, as there was no conclusive evidence of compromised physical or electrical integrity of the lead.This condition may develop over time and can be reflected in a gradual and sustained increase in shock impedance measurements.Boston scientific issued a field safety notice to physicians in july 2025 regarding the potential for reliance defibrillation leads with expanded polytetrafluoroethylene (eptfe) coating to exhibit a pattern of gradually increasing lvsi measurements due to calcification, which may result in elevated high-voltage shock impedance (hvsi) measurements and reduced shock efficacy.Device history: 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.Labeling review: 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.Risk assessment: a risk review was completed and confirmed that the event of shock impedance high out of range - increasing gradually 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to device design.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE DEFIBRILLATOR 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22641832
• Report Number: 2124215-2025-51031
• Device Sequence Number: 5194097
• Product Code: NVY
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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: 10/21/2013
• Device Model Number: 0285
• Device Catalogue Number: 0285
• Device Lot Number: 102133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 06/01/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/17/2025; 06/03/2026
• Date Device Manufactured: 10/21/2011
• 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: 47 YR
• Patient Sex: Male