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

Model Number 0138

Device Problems Failure to Capture (1081); Contamination /Decontamination Problem (2895)

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

Event Date 04/09/2024

Event Type  malfunction  

Event Description

It was reported that there were concerns this right ventricular (rv) lead exhibited loss of capture (loc) due to elevated right ventricular autothreshold (rvat) test results.Technical services (ts) reviewed the reports and noted that it is hard to say if there was true loc.Ts noted that it could be fusion beats.The rvat resulted in the max rvat output.Ts stated that they were not able to see the test that resulted in that output.The threshold lowered since that event and has remained stable.The caller wanted to know if they should bring in patient for evaluation.Ts advised that is clinic discretion.The lead remains in use.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE S
• 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: 19215708
• MDR Text Key: 341620195
• Report Number: 2124215-2024-26182
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531118
• UDI-Public: 00802526531118
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S039
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0138
• Device Catalogue Number: 0138
• Device Lot Number: 306518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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: 83 YR
• Patient Sex: Male