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

Model Number 7841

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

Patient Problems Chest Pain (1776); Pleural Effusion (2010); Cardiac Perforation (2513)

Event Date 02/21/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited loss of capture as seen on the telemetry followed by polymorphic ventricular tachycardia (vt) soon after the lead was implanted.Boston scientific representative stated that chest x-ray imaging was ordered to check on lead position.Bsc representative stated that the slack had completely pulled back on the rv lead and recommended to have lead revision.It was confirmed that this lead was perforated and there was pleural effusion along with chest pain.There were sensing issues noted as well.Subsequently this lead was explanted, and a new rv lead was successfully implanted.No additional patient adverse 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: 18816434
• MDR Text Key: 336661478
• Report Number: 2124215-2024-12545
• Device Sequence Number: 1
• Product Code: NVN
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1409071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/01/2024
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female