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

Model Number 7742

Device Problems Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)

Patient Problems Bradycardia (1751); Fatigue (1849); Insufficient Information (4580)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead exhibited an increase in impedance measurements and high capture thresholds.Additionally, the patient was reported to be symptomatic and fatigued and experienced a heart rate of 30 beats per minute (bpm) on their pulse oximeter.Boston scientific technical services (ts) confirmed loss of capture (loc) on this lead.Further testing was recommended.No additional adverse patient effects were reported.At this time, this lead remains in service.

• Brand Name: INGEVITY MRI
• 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: 19000983
• MDR Text Key: 338912307
• Report Number: 2124215-2024-18654
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523489
• UDI-Public: 00802526523489
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2020
• Device Model Number: 7742
• Device Catalogue Number: 7742
• Device Lot Number: 860546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• 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: 68 YR
• Patient Sex: Male