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

Model Number 7841

Device Problem Difficult to Insert (1316)

Patient Problems Dyspnea (1816); Perforation (2001); Pneumothorax (2012)

Event Date 06/14/2023

Event Type  Injury  

Event Description

It was reported that during implant, it was difficult to obtain venous access and multiple attempts were required.The device system implant was ultimately completed successfully and the pocket closed.Then, upon transferring the patient onto the bed, the patient experienced sudden shortness of breath.The patient went to recovery and was able to talk and converse with assistance from the breathing mask.Chest x-ray was performed and small left-sided pneumothorax was confirmed by a dark area on the upper left side of the chest wall.It was then mentioned that the pneumothorax was suspected to be caused by multiple attempts at obtaining vascular access with the introducer needle.The patient was then transferred to the intensive care unit (icu) for treatment, and a chest drain was performed and then the patient was transferred back to the icu for continuous monitoring.The device system remains in service.The patient was discharged from the hospital and no additional adverse patient effects were reported.

Event Description

It was reported that during implant, it was difficult to obtain venous access and multiple attempts were required.The device system implant was ultimately completed successfully and the pocket closed.Then, upon transferring the patient onto the bed, the patient experienced sudden shortness of breath.The patient went to recovery and was able to talk and converse with assistance from the breathing mask.Chest x-ray was performed and small left-sided pneumothorax was confirmed by a dark area on the upper left side of the chest wall.It was then mentioned that the pneumothorax was suspected to be caused by multiple attempts at obtaining vascular access to implant the above-referenced lead.The patient was then transferred to the intensive care unit (icu) for treatment, and a chest drain was performed and then the patient was transferred back to the icu for continuous monitoring.The device system remains in service.The patient was discharged from the hospital and no additional adverse patient effects were reported.

Manufacturer Narrative

Correction: fields b2 (outcomes attrib to adv event) and d.(suspect medical device) were updated.

• 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: 17249126
• MDR Text Key: 318344904
• Report Number: 2124215-2023-34557
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1272047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female