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

Model Number 7735

Device Problems Difficult to Insert (1316); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this right atrial (ra) lead was attempted due to the lead keep getting caught in the sheath during procedure and was suspected that the lead might have been damaged or malfunctioning when the sheath was inserted.The lead did not bend properly into a j-shape and could not be placed, due to patient-related factors.The lead was never in service and was replaced with the same model.No adverse patient effects were reported.

Event Description

It was reported that this right atrial (ra) lead was attempted due to the lead keep getting caught in the sheath during procedure and was suspected that the lead might have been damaged or malfunctioning when the sheath was inserted.The lead did not bend properly into a j-shape and could not be placed, due to patient-related factors.The lead was never in service and was replaced with the same model.No adverse patient effects were reported.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, the device was forwarded to detailed analysis for further investigation.Data analysis confirmed the issue of lead damaged.Based on the finding of stretched inner conductor coils near the tip of the lead.

• 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: 18194299
• MDR Text Key: 328825009
• Report Number: 2124215-2023-66204
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7735
• Device Catalogue Number: 7735
• Device Lot Number: 1009893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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: 77 YR
• Patient Sex: Female