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

Model Number 7842

Device Problems Failure to Capture (1081); Difficult to Insert (1316); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

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

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the lead found that the helix mechanism was extended and dried blood was noted in the helix housing.A stylet passed through the lead, but with resistance felt due to blood/body fluid which broke apart as the stylet was pushed forward.Based upon the clinical observations and the laboratory findings, we believe that body fluid inside the helix housing may have contributed to the irregularity in helix function and stylet insertion.Then testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations regarding loss of capture allegation.

Event Description

It was reported that during implant procedure this right ventricular (rv) lead was an attempt due to dislodgment, placement difficulty and loss of capture with asystole less than 2 seconds.It was noted that the lead lost slack and got dislodged after surgery.Subsequently, the physician tried to repositioned the lead on the same day, nonetheless the stylet was difficult to insert and the helix did not extend after stylet insertion.This rv lead successfully replaced.No additional 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: 13908164
• MDR Text Key: 288129057
• Report Number: 2124215-2022-00628
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: 00802526604522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2023
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1058975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male