MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; PERMANENT DEFIBRILLATION ELECTRODE

Model Number 0672

Device Problems Signal Artifact/Noise (1036); Mechanical Problem (1384); Contamination /Decontamination Problem (2895); Positioning Problem (3009); Device Contaminated at the User Facility (4064)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead exhibited poor measurements during the implant procedure.Noise from interaction with an abandoned lead was also observed.The lead was repositioned four times, but the measurements did not improve; the lead dislodged during the procedure when placed in the right ventricular outflow tract (rvot).After this, the helix would not fully extend.The lead was removed from the patient and tissue was noted entwined on the helix.The tissue was removed but still the helix did not fully extend and the procedure was completed with a new lead of the same model.No adverse patient effects were reported.The attempted lead was expected to be returned for analysis.

Event Description

It was reported that this right ventricular (rv) lead exhibited poor measurements during the implant procedure.Noise from interaction with an abandoned lead was also observed.The lead was repositioned four times, but the measurements did not improve; the lead dislodged during the procedure when placed in the right ventricular outflow tract (rvot).After this, the helix would not fully extend.The lead was removed from the patient and tissue was noted entwined on the helix.The tissue was removed but still the helix did not fully extend and the procedure was completed with a new lead of the same model.No adverse patient effects were reported.The attempted lead was returned for analysis.

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.A new stylet was inserted into the lead lumen without resistance.No tissue was observed in the helix, and the laboratory technician tested the helix mechanism and found it functioned as expected.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: RELIANCE 4-FRONT
• Type of Device: PERMANENT DEFIBRILLATION ELECTRODE
• 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: 14164783
• MDR Text Key: 289733642
• Report Number: 2124215-2022-12209
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• PMA/PMN Number: P910073/S145
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2023
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 172471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male