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

Model Number	0181
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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.
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 information was received that this right ventricular (rv) lead was explanted and replaced with a new rv lead.A return request is being sent.No additional adverse patient effects were 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 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 information was received that this right ventricular (rv) lead was explanted and replaced with a new rv lead.A return request is being sent.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The lead was returned in two severed segments approximately 135 millimeters from the terminal end with an extracting stylet stuck in the tip section of the lead.Surface abrasion was noted approximately 370mm from the tip end.Cuts in the suture sleeve and insulation were observed consistent with explant damage.Testing was completed to assess lead electrical performance.Measurements throughout this test was within normal limits.Visual examination of the lead noted calcification on the outer insulation, shocking coils and helix.Investigation of the available information/data determined that the observed gradual rise in low voltage shock impedance (lvsi) measurements was associated with calcification, as there was no conclusive evidence of compromised 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.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The lead was returned in two severed segments approximately 135 millimeters from the terminal end with an extracting stylet stuck in the tip section of the lead.Surface abrasion was noted approximately 370mm from the tip end.Cuts in the suture sleeve and insulation were observed consistent with explant damage.Testing was completed to assess lead electrical performance.Measurements throughout this test was within normal limits.Visual examination of the lead noted calcification on the outer insulation, shocking coils and helix.Investigation of the available information/data determined that the observed gradual rise in low voltage shock impedance (lvsi) measurements was associated with calcification, as there was no conclusive evidence of compromised 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.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 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.
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 information was received that this right ventricular (rv) lead was explanted and replaced with a new rv lead.A return request is being sent.No additional adverse patient effects were reported.

• 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; 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: 22668162
• Report Number: 2124215-2025-52327
• Device Sequence Number: 7533629
• Product Code: LWS
• UDI-Device Identifier: 00802526531156
• UDI-Public: (01)00802526531156(17)160218
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 02/18/2016
• Device Model Number: 0181
• Device Catalogue Number: 0181
• Device Lot Number: 325847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 01/27/2026; 03/24/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/20/2025; 02/20/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2014
• 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: 43 YR
• Patient Sex: Female