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

Model Number	0180
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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 Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
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 will be sent to the field for this rv lead.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.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 unable to exclude device problem.
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 will be sent to the field for this rv lead.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: 22646849
• Report Number: 2124215-2025-51443
• Device Sequence Number: 8827961
• Product Code: LWS
• UDI-Device Identifier: 00802526531149
• UDI-Public: (01)00802526531149(17)150823
• 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: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 08/23/2015
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Device Lot Number: 309937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 11/12/2025; 03/26/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/19/2025; 11/17/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2013
• 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: 58 YR
• Patient Sex: Male