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

Model Number 7840

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problem Twiddlers Syndrome (4563)

Event Date 03/18/2024

Event Type  Injury  

Event Description

It was reported that the right atrial (ra) lead exhibited high, out-of-range pacing impedance measurements measuring 2,200 ohms and high thresholds measuring 2.7v.It was noted that impedances and thresholds have been rising over the last year.Subsequently, a lead revision was performed and upon opening the pocket the ra and right ventricular (rv) leads were braided together.The ra lead was explanted and removed successfully.The ra lead is expected to be returned for analysis.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: 19002952
• MDR Text Key: 338890136
• Report Number: 2124215-2024-19037
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604430
• UDI-Public: 00802526604430
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2023
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 1043061
• 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: 08/30/2021
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female