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

Model Number 0672

Device Problems Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problems Device Overstimulation of Tissue (1991); Cardiac Perforation (2513)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead high pacing thresholds, phrenic nerve stimulation, and dislodgement.Lead perforation was also suspected; however, no additional intervention was required.A new rv lead was successfully placed.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.The lead was returned intact (not severed) with the helix mechanism in a retracted position.Setscrew marks were in the correct location on the terminal pin.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.Laboratory testing is not able to provide relevant information for the type of allegations made on this case, but 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.

Event Description

It was reported that this right ventricular (rv) lead showed high pacing thresholds, phrenic nerve stimulation, and dislodgement.Lead perforation was also suspected; however, no additional intervention was required.A new rv lead was successfully placed.No additional adverse patient effects were reported.The device was returned for analysis.

• 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: 16564643
• MDR Text Key: 311491055
• Report Number: 2124215-2023-12734
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 192588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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): Required Intervention; Hospitalization