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

Model Number 7841

Device Problems Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during implant procedure, when the j shaped stylet was inserted in this right atrial (ra) lead, the tip of the stylet kinked and got stuck within the lead's terminal end.Also, after the stylet was removed, no other stylet could be inserted in this lead.Additional information from the field representative indicates that the damage was induced after the first stylet was inserted, reportedly it was inserted too forcefully, which damaged the lead's terminal end.After the stylet was removed, every other stylet could not be inserted fully through the lead terminal.Therefore, this lead was removed prior to pocket closure and another lead was implanted to complete the procedure.No adverse patient effects.The complaint device was not returned by the customer; therefore, no product analysis could be performed.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations of damage at the terminal end, stylet insertion difficulty and stylet kinked.

Event Description

It was reported that during implant procedure, when the j shaped stylet was inserted in this right atrial (ra) lead, the tip of the stylet kinked and got stuck within the lead's terminal end.Also, after the stylet was removed, no other stylet could be inserted in this lead.Additional information from the field representative indicates that the damage was induced after the first stylet was inserted, reportedly it was inserted too forcefully, which damaged the lead's terminal end.After the stylet was removed, every other stylet could not be inserted fully through the lead terminal.Therefore, this lead was removed prior to pocket closure and another lead was implanted to complete the procedure.No adverse patient effects.The product was returned for analysis.

• Brand Name: INGEVITY+
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10723311
• MDR Text Key: 212696862
• Report Number: 2124215-2020-21590
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: 00802526604577
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2022
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1008643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 11/02/2020
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 125