MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0673

Device Problems Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Dislodged or Dislocated (2923)

Patient Problem Electric Shock (2554)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead was explanted due to low impedance measurements and low sensing days after implant.During lead revision, lead dislodgement to the right atrium was noticed.In addition, the patient the patient received and inappropriate shock for atrial fibrillation (af).The rv lead was explanted and replaced.No additional adverse patient effects were reported.

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/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies other than blood or body fluid in the lumen due to damaged insulation and cut in the suture sleeve likely due to explant damage.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.The reported issue is issue covered by the instructions for use (ifu) - and therefore is deemed a known inherent risk of the device.

Event Description

It was reported that this right ventricular (rv) lead was explanted due to low impedance measurements and low sensing days after implant.During lead revision, lead dislodgement to the right atrium was noticed.In addition, the patient the patient received and inappropriate shock for atrial fibrillation (af).The rv lead was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• 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: 16077440
• MDR Text Key: 306418883
• Report Number: 2124215-2022-55561
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 180210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male