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

Model Number	0286
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a pulse generator change-out, this right ventricular (rv) lead exhibited high capture thresholds and loss of capture (loc).The lead was tested using a pacing system analyzer and the elevated thresholds persisted.A review of the stored data revealed the threshold increased during the previous 6 months; however, impedance and sensing measurements were normal and a chest x-ray showed no abnormalities.The treating physician performed a venography that showed the patient anatomy had a closed access.The patient is not pacing dependent, so the physician elected to program rv pacing off.No adverse patient effects were reported.The device is not expected to be returned.Additional information received indicated that this right ventricular (rv) lead had no capture and there were high capture thresholds.Lead fracture was suspected.Sensing and shock impedances were within the normal range, and no noise was noted.Subsequently this lead was surgically abandoned, and a new lead was successfully replaced.No additional patient adverse effects were reported.
Additional Manufacturer Narrative
This report contains additional information in section b1 adverse event/product problem, b2 outcomes attrib to adv event, b5 describe event or problem, h1 type of reportable event, h2 if follow-up, what type and h6 impact codes.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24059486
• Report Number: 2124215-2026-02207
• Device Sequence Number: 15807817
• Product Code: NVY
• UDI-Device Identifier: 00802526431418
• UDI-Public: 00802526431418
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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: Health Professional
• Device Expiration Date: 05/01/2011
• Device Model Number: 0286
• Device Catalogue Number: 0286
• Device Lot Number: 013719
• 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: 01/10/2026
• Initial Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 07/21/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown