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

Model Number 7841

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Positioning Problem (3009); Device Contaminated at the User Facility (4064)

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

Event Date 05/19/2023

Event Type  Injury  

Event Description

It was reported that this right atrial (ra) lead was dislodged.It was confirmed through x-rays.The lead was successfully repositioned.One week later the lead got dislodged again so the physician decided to explant the lead and replace it due to it was difficult to insert because there was tissue in the electrode end.No additional adverse patient effects were reported.

Manufacturer Narrative

This lead was returned to our post market quality assurance laboratory with the helix mechanism in a retracted position.Visual inspection found dried blood around the helix.Subsequent testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported helix extension/retraction problems.

Event Description

It was reported that this right atrial (ra) lead was dislodged.It was confirmed through x-rays.The lead was successfully repositioned.One week later the lead got dislodged again so the physician decided to explant the lead and replace it due to it was difficult to insert because it had tissue.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: 17075763
• MDR Text Key: 316661602
• Report Number: 2124215-2023-28898
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: 00802526604577
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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: 1251569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2023
• 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 Sex: Male