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

Model Number 7842

Device Problems Failure to Capture (1081); Mechanical Problem (1384); Off-Label Use (1494)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that this lead was unable to be implanted due to helix issues.No additional information is available at the moment.No additional adverse patient effects were reported.Additional information was obtained, this lead helix was extended into the septum, the placement was not capturing so the physician was attempting to retract the helix and remove the lead from the septum.The helix would not retract, which was confirmed through fluoroscopy.No additional information is available at the moment.No additional adverse patient effects were reported.

Event Description

It was reported that this lead was unable to be implanted due to helix issues.No additional information is available at the moment.No additional adverse patient effects were reported.Additional information was obtained, this lead helix was extended into the septum, the placement was not capturing so the physician was attempting to retract the helix and remove the lead from the septum.The helix would not retract, which was confirmed through fluoroscopy.No additional information is available at the moment.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: 18968765
• MDR Text Key: 338697768
• Report Number: 2124215-2024-17804
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: 00802526604522
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1283983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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 Age: 82 YR
• Patient Sex: Male