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

Model Number 7841

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Syncope/Fainting (4411)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that the patient with the implantable cardioverter defibrillator (icd) device reported syncopal event.This right atrial (ra) lead exhibited loss of capture (loc) as this episode was stored on the presenting electrogram (egm).As per the health care professional (hcp), the electrophysiology (ep) was aware of the ra lead dislodgement as it was confirmed by chest x-ray and will be addressing this issue.This ra lead currently remains in service.No 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: 18978810
• MDR Text Key: 338601210
• Report Number: 2124215-2024-18146
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1408339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2024
• 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 Age: 76 YR
• Patient Sex: Male