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

Model Number 7742

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Positioning Problem (3009)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was stretched and bent, and dried blood/tissue was present around the helix.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the inner conductor coil had a break at the distal end of the terminal pin.Based upon the clinical observations and the laboratory findings, we believe that torsional overstress during attempts to extend/retract the helix caused the inner conductor coil to break.The identified break contributed to the reported clinical observations.

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant due to helix issues and placement difficulty.The helix mechanism was extended when attempting to insert the lead, and was unable to be retracted.

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant due to helix issues and placement difficulty.The helix mechanism was extended when attempting to insert the lead, and was unable to be retracted.

Manufacturer Narrative

This report is being filed to correct an error in the previously submitted device codes (h6).Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was stretched and bent, and dried blood/tissue was present around the helix.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the inner conductor coil had a break at the distal end of the terminal pin.Based upon the clinical observations and the laboratory findings, we believe that torsional overstress during attempts to extend/retract the helix caused the inner conductor coil to break.The identified break contributed to the reported clinical observations.

• 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: 15124460
• MDR Text Key: 296970990
• Report Number: 2124215-2022-27944
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: PO
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 7742
• Device Catalogue Number: 7742
• Device Lot Number: 1182858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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