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

Model Number 7841

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Device Contaminated at the User Facility (4064)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced heart palpitations, so they went in for a check up and they were examined with x-ray imaging.This right atrial (ra) lead dislodged and was attempted to be repositioned but it would not reattach due to tissue in the helix.A new device was implanted.No additional 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 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 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.

Event Description

It was reported that the patient experienced heart palpitations, so they went in for a check up and they were examined with x-ray imaging.This right atrial (ra) lead dislodged and was attempted to be repositioned but it would not reattach due to tissue in the helix.A new device was implanted.The device has been returned and was analyzed.No additional 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: 16559228
• MDR Text Key: 311470839
• Report Number: 2124215-2023-12582
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: 00802526604577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 1202626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Male