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

Model Number	0185
Medical Device Problem Codes	High impedance (1291); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine checkup visit a week post generator replacement procedure, this implantable cardioverter defibrillator (icd) device was observed to exhibit high out of range shock impedances on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the daily threshold and impedance measurements.Ts reviewed the reports and confirmed rv lead shock impedances to have been stable with the old generator, however those rv lead impedances appeared to have increased to be greater than 125 ohms with the new icd device.Ts discussed possible causes and recommended for further evaluation to be performed.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that during a routine checkup visit a week post generator replacement procedure, this implantable cardioverter defibrillator (icd) device was observed to exhibit high out of range shock impedances on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the daily threshold and impedance measurements.Ts reviewed the reports and confirmed rv lead shock impedances to have been stable with the old generator, however those rv lead impedances appeared to have increased to be greater than 125 ohms with the new icd device.Ts discussed possible causes and recommended for further evaluation to be performed.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.Additional information was received indicated that a follow up visit was performed where xray images were taken.It was suspected that the rv lead to have dislodged at the pin site or possible connection issue however the images were unclear.Technical services (ts) recommended for further evaluation like tug test to be completed.The clinician plans on scheduling patient for an in person visit for further evaluation.At this time, no additional adverse patient effects were reported.This rv lead and icd remain in service.
Additional Manufacturer Narrative
This product remains implanted and in-service.As such, physical analysis has not been conducted in our laboratory.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Additional Manufacturer Narrative
This product remains implanted and in-service.As such, physical analysis has not been conducted in our laboratory.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that during a routine checkup visit a week post generator replacement procedure, this implantable cardioverter defibrillator (icd) device was observed to exhibit high out of range shock impedances on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the daily threshold and impedance measurements.Ts reviewed the reports and confirmed rv lead shock impedances to have been stable with the old generator.However, those rv lead impedances appeared to have increased to be greater than 125 ohms with the new icd device.Ts discussed possible causes and recommended for further evaluation to be performed.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.Additional information was received indicated that a follow up visit was performed where xray images were taken.It was suspected that the rv lead to have dislodged at the pin site or possible connection issue however the images were unclear.Technical services (ts) recommended for further evaluation like tug test to be completed.The clinician plans on scheduling patient for an in person visit for further evaluation.At this time, no additional adverse patient effects were reported.This rv lead and icd remain in service.Subsequently, additional information was received reported that the physician performed a pocket exploration revision procedure, where it was found that the rv lead was not fully connected to the device.The physician fully connected the rv lead to the device and the impedance issues was successfully resolved.No additional adverse patient effects were reported.The rv lead and icd remain in service.
Event or Problem Description
It was reported that during a routine checkup visit a week post generator replacement procedure, this implantable cardioverter defibrillator (icd) device was observed to exhibit high out of range shock impedances on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the daily threshold and impedance measurements.Ts reviewed the reports and confirmed rv lead shock impedances to have been stable with the old generator.However, those rv lead impedances appeared to have increased to be greater than 125 ohms with the new icd device.Ts discussed possible causes and recommended for further evaluation to be performed.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.Additional information was received indicated that a follow up visit was performed where xray images were taken.It was suspected that the rv lead to have dislodged at the pin site or possible connection issue however the images were unclear.Technical services (ts) recommended for further evaluation like tug test to be completed.The clinician plans on scheduling patient for an in person visit for further evaluation.At this time, no additional adverse patient effects were reported.This rv lead and icd remain in service.Subsequently, additional information was received reported that the physician performed a pocket exploration revision procedure, where it was found that the rv lead was not fully connected to the device.The physician fully connected the rv lead to the device and the impedance issues was successfully resolved.No additional adverse patient effects were reported.The rv lead and icd remain in service.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific and physical analysis could not be conducted.Device history record review: 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 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 not established.

• 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): 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: 23381449
• Report Number: 2124215-2025-76589
• Device Sequence Number: 4902500
• Product Code: LWS
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 07/18/2015
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Device Lot Number: 354855
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 03/19/2026; 04/06/2026; 06/29/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 04/03/2026; 04/24/2026; 07/01/2026
• Date Device Manufactured: 07/18/2013
• 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: 72 YR
• Patient Sex: Male