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

Model Number	0137
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine follow-up, this right ventricular (rv) lead exhibited high pacing thresholds.Fluoroscopy imaging was performed, and it was discovered that the lead position was the cause of the high pacing thresholds.The rv lead was explanted and successfully replaced with a new lead.No additional adverse patient effects were reported.The lead is expected to return.
Event or Problem Description
It was reported that during a routine follow-up, this right ventricular (rv) lead exhibited high pacing thresholds.Fluoroscopy imaging was performed, and it was discovered that the lead position was the cause of the high pacing thresholds.The rv lead was explanted and successfully replaced with a new lead.No additional adverse patient effects were reported.This lead was returned, and analysis was performed.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner and outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, and electrode tip found no anomalies.Dried body fluid and tissue were noted in the helix housing which is normal for active fixation leads.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ENDOTAK RELIANCE S
• 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; 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: 17185690
• Report Number: 2124215-2023-32534
• Device Sequence Number: 6495010
• Product Code: LWS
• UDI-Device Identifier: 00802526531101
• UDI-Public: 00802526531101
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 06/10/2023
• Device Model Number: 0137
• Device Catalogue Number: 0137
• Device Lot Number: 301143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male