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

Model Number 7842

Device Problems Failure to Capture (1081); High impedance (1291); Off-Label Use (1494); Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported that, this right ventricular (rv) lead placed in the left bundle branch (lbb), was an attempted during implant procedure.After three rounds of the physician extending the helix, the rv lead exhibited loss of capture (loc) and a decrease in the pacing impedance.Subsequently, the rv lead was removed and replaced.The physician examined the helix and tissue was found.The physician used forceps to remove tissue and it is unknown if this causes the helix to be bent or if it was during deployment into lbb.No adverse patient effects were reported.

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.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly and lead body found no anomalies, nonetheless, s helix mechanism test did not pass due to the helix being deformed.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.

Event Description

It was reported that, this right ventricular (rv) lead placed in the left bundle branch (lbb), was an attempted during implant procedure.After three rounds of the physician extending the helix, the rv lead exhibited loss of capture (loc) and a decrease in the pacing impedance.Subsequently, the rv lead was removed and replaced.The physician examined the helix and tissue was found.The physician used forceps to remove tissue and it is unknown if this causes the helix to be bent or if it was during deployment into lbb.No 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: 18540746
• MDR Text Key: 333217799
• Report Number: 2124215-2024-02636
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: 00802526604522
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1267994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2023
• 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: 69 YR
• Patient Sex: Male