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

Model Number	0174
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Health Effect - Clinical Codes	Fever (1858); Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort was made to retrieve additional information regarding resolution.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited out of range shock lead impedance measurements.Technical services (ts) referred this patient to the clinic.This lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was made to retrieve additional information regarding resolution.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited out of range shock lead impedance measurements.Technical services (ts) referred this patient to the clinic.This lead remains in service.No adverse patient effects were reported.Additional information was received that this rv lead provided inappropriate shocks and anti-tachycardia pacing (atp) therapy for 1:1 supraventricular tachycardia (supraventricular tachycardia (svt), therapy was exhausted, and shock impedance measurements were greater than 125 ohms.The patient was septic with a high-grade fever at the time of the therapy, and the patient was admitted to the hospital.Ts recommended rv lead replacement.At this time this lead remains in service.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• 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: 22473677
• Report Number: 2124215-2025-46216
• Device Sequence Number: 17170469
• Product Code: LWS
• UDI-Device Identifier: 00802526373640
• UDI-Public: (01)00802526373640(17)121210
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 12/10/2012
• Device Model Number: 0174
• Device Catalogue Number: 0174
• Device Lot Number: 107124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 01/26/2026
• Date Device Manufactured: 12/10/2010
• 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: 35 YR
• Patient Sex: Female