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

Model Number 7841

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Low impedance (2285); Device Sensing Problem (2917)

Patient Problems Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  Injury  

Event Description

It was reported that the patient with the pacemaker device exhibited noisy signals and loss of capture (loc) on this right ventricular (rv) channel.The rv impedances went half from what the measurements were during implant.This rv lead currently remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This report contains correction in entire section e initial reporter and section g2 report source.

Event Description

It was reported that the patient with the pacemaker device exhibited noisy signals and loss of capture (loc) on this right ventricular (rv) channel.The rv impedances went half from what the measurements were during implant.This rv lead currently remains in service.No adverse patient effects were reported.

Event Description

It was reported that the patient with the pacemaker device exhibited noisy signals and loss of capture (loc) on this right ventricular (rv) channel.The rv impedances went half from what the measurements were during implant.This rv lead currently remains in service.No adverse patient effects were reported.Additional information received indicated that this rv lead was repositioned.The patient was brought into emergency room (er) the night before the reposition procedure and this patient was said to have had a syncopal event and was hypotensive.Troubleshooting was performed and x-ray imagining was reviewed.After device interrogation the following was noted, loss of ventricular capture at max output, noticeable decrease in rv lead impedance from implant and variable decreased sensing.Subsequently this rv lead was repositioned and confirmed to be electronically stable.Prior to patient leaving the lab an echocardiogram was performed to assess pericardial effusion.The physician noted that the patient's pericardial effusion had improved significantly.A post operative check was performed the next morning and patient stated to have felt much better.No additional patient adverse effects were reported.

Manufacturer Narrative

This report contains additional information in section b5 describe event or problem, section h1 type of reportable event, section h6 patient codes and impact codes.This report contains correction in entire section e initial reporter and section g2 report source.

• 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: 18998483
• MDR Text Key: 338988352
• Report Number: 2124215-2024-18843
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: 00802526604577
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1405708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 03/30/2024; 03/30/2024
• Supplement Dates FDA Received: 04/01/2024; 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female