MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0170
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2015
Type of Reportable Event	Malfunction
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 this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) exhibited shock impedance measurements of greater than 125 ohms dating back to two thousand and fifteen.The icd is at elective replacement indicator (eri).Technical services (ts) discussed possible shock test for impedances and go from there.This rv lead and icd remain in service at this time.No 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 this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) exhibited shock impedance measurements of greater than 125 ohms dating back to two thousand and fifteen.The icd is at elective replacement indicator (eri).Technical services (ts) discussed possible shock test for impedances and go from there.This rv lead and icd remain in service at this time.No adverse patient effects were reported.Additional information was received that this icd was explanted and rv lead remained implanted with a within normal range shock impedance measurement of 106 ohms.This rv lead remains in service.No 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 this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) exhibited shock impedance measurements of greater than 125 ohms dating back to two thousand and fifteen.The icd is at elective replacement indicator (eri).Technical services (ts) discussed possible shock test for impedances and go from there.This rv lead and icd remain in service at this time.No adverse patient effects were reported.Additional information was received that this icd was explanted and rv lead remained implanted with a within normal range shock impedance measurement of 106 ohms.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this rv lead exhibited a gradual rise in shock impedance measurements, eventually going out of range, indicating calcification.Additionally, pace impedance has varied between 1000 and 1400 since this patient had their device change out.Threshold measurements were within normal range and no noise has been observed.Ts discussed that since this patients device change out the shock impedance has plateaued however discussed considering a defibrillation threshold (dft) test as this patient had previously undergone a dft during the device change out which was successful.This rv lead remains in service at this time.
Event or Problem Description
It was reported that this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) exhibited shock impedance measurements of greater than 125 ohms dating back to two thousand and fifteen.The icd is at elective replacement indicator (eri).Technical services (ts) discussed possible shock test for impedances and go from there.This rv lead and icd remain in service at this time.No adverse patient effects were reported.Additional information was received that this icd was explanted and rv lead remained implanted with a within normal range shock impedance measurement of 106 ohms.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this rv lead exhibited a gradual rise in shock impedance measurements, eventually going out of range, indicating calcification.Additionally, pace impedance has varied between 1000 and 1400 since this patient had their device change out.Threshold measurements were within normal range and no noise has been observed.Ts discussed that since this patients device change out the shock impedance has plateaued however discussed considering a defibrillation threshold (dft) test as this patient had previously undergone a dft during the device change out which was successful.This rv lead remains in service at this time.
Additional Manufacturer Narrative
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 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.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to device design.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16954989
• Report Number: 2124215-2023-24914
• Device Sequence Number: 3613636
• Product Code: LWS
• UDI-Device Identifier: 00802526373282
• UDI-Public: 00802526373282
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/11/2013
• Device Model Number: 0170
• Device Catalogue Number: 0170
• Device Lot Number: 100684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 11/12/2025; 03/26/2026
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/05/2023; 11/19/2025; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2011
• 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
• Patient Age: 54 YR
• Patient Sex: Female