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

Model Number 7842

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Bradycardia (1751)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported that approximately ten days after being implanted, the patient with this right ventricular (rv) lead went to the hospital due to bradycardia.The patient was checked by the physician and bradycardia was confirmed, after which fluoroscopy was performed and temporary pacing was put in place.Fluoroscopy showed the rv lead was dislodged and a lead revision procedure was performed, however, during the procedure, the lead helix was unable to be moved.As a result, the lead was explanted and successfully replaced.No additional adverse patient effects were reported.The lead is expected to be returned for analysis.

Event Description

It was reported that approximately ten days after being implanted, the patient with this right ventricular (rv) lead went to the hospital due to bradycardia.The patient was checked by the physician and bradycardia was confirmed, after which fluoroscopy was performed and temporary pacing was put in place.Fluoroscopy showed the rv lead was dislodged and a lead revision procedure was performed, however, during the procedure, the lead helix was unable to be moved.As a result, the lead was explanted and successfully replaced.No additional adverse patient effects were reported.Boston scientific has made three attempts to retrieve the device, however; no response was received, the device is not expected to be returned.

• 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: 18413963
• MDR Text Key: 331552472
• Report Number: 2124215-2023-74265
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1253577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female