MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY+; IMPLANTABLE LEAD

Model Number 7841

Device Problems Failure to Capture (1081); Mechanical Problem (1384); Difficult to Remove (1528); Contamination /Decontamination Problem (2895)

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

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead was explanted due to a right ventricle perforation.A new lead was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Corrected fields: b5.Describe event or problem h6.Device and impact codes.

Event Description

It was reported that this right ventricular (rv) lead was explanted due to a right ventricle perforation which led to loss of capture (loc) and diaphragmatic stimulation.When attempting to reposition, the lead was difficult to remove since the helix would not fully retract after more than 50 turns with the fixation tool.Upon removal, there was tissue within the helix that was preventing the full retraction of the helix.A new lead was implanted.No additional adverse patient effects were reported.

• Brand Name: INGEVITY+
• 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: 18890004
• MDR Text Key: 337489252
• Report Number: 2124215-2024-14975
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: 00802526604577
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1404091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2024
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female