MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0286
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This implantable cardioverter defibrillator (icd) system exhibited elevated and fluctuating right ventricular (rv) lead impedance following a generator replacement.Historical data showed a gradual rise in impedance prior to replacement, followed by an expected drop with the new device, then minor fluctuations.No pacing inhibition or rv lead noise was observed.Due to the variability, technical services recommended further in-office evaluation to rule out under-insertion or intermittent lead fracture.Slightly elevated power consumption was attributed to persistent at/af and high rv sensing rate.The device is depleting normally, no malfunction was identified, and no adverse patient effects were reported.The system remains in service.
Event or Problem Description
This implantable cardioverter defibrillator (icd) system exhibited elevated and fluctuating right ventricular (rv) lead impedance following a generator replacement.Historical data showed a gradual rise in impedance prior to replacement, followed by an expected drop with the new device, then minor fluctuations.No pacing inhibition or rv lead noise was observed.Due to the variability, technical services recommended further in office evaluation to rule out under insertion or intermittent lead fracture.Slightly elevated power consumption was attributed to persistent at/af and high rv sensing rate.The device is depleting normally, no malfunction was identified, and no adverse patient effects were reported.The system remains in service.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 22480264
• Report Number: 2124215-2025-46465
• Device Sequence Number: 20957014
• Product Code: NVY
• UDI-Device Identifier: 00802526431418
• UDI-Public: (01)00802526431418(17)151204
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 12/04/2015
• Device Model Number: 0286
• Device Catalogue Number: 0286
• Device Lot Number: 105316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 12/04/2013
• 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
• Patient Age: 60 YR
• Patient Sex: Male