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

Model Number 0293

Device Problems Failure to Capture (1081); Under-Sensing (1661); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the patient with implantable cardioverter defibrillator (icd) device exhibited loss of capture (loc) and high capture thresholds on this right ventricular (rv) channel.The health care professional (hcp) called in to review the atrial tachy response (atr) episode and technical services (ts) stated that the ventricular pacing beats during the fallback did not appear to capture.The threshold values went from 1v to 2.5v.Ts recommended to have the patient bring in for threshold testing.This rv lead remains in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: 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: 18959439
• MDR Text Key: 338363866
• Report Number: 2124215-2024-17474
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531255
• UDI-Public: 00802526531255
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2018
• Device Model Number: 0293
• Device Catalogue Number: 0293
• Device Lot Number: 369647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male