MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES

Model Number 7742

Device Problems Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker system was scheduled for a magnetic resonance imaging (mri) scan.However the pacemaker could not be placed in mri protection mode as the right ventricular (rv) lead was programmed to unipolar mode.Further rv lead evaluation revealed high out-of-range pace impedance measurements greater than 3,000 ohms and rv non-capture at 1.7v.This pacemaker system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this pacemaker system was scheduled for a magnetic resonance imaging (mri) scan.However the pacemaker could not be placed in mri protection mode as the right ventricular (rv) lead was programmed to unipolar mode.Further rv lead evaluation revealed high out-of-range pace impedance measurements greater than 3,000 ohms and rv non-capture at 1.7v.This pacemaker system remains in service.No adverse patient effects were reported.Additional information received reported that the physician elected not to proceed with the magnetic resonance imaging (mri) scan, and will review next steps with the patient.This pacemaker system remains in service.No adverse patient effects were reported.

• Brand Name: INGEVITY MRI
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES
• 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: 18812924
• MDR Text Key: 336650571
• Report Number: 2124215-2024-12391
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523489
• UDI-Public: 00802526523489
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2021
• Device Model Number: 7742
• Device Catalogue Number: 7742
• Device Lot Number: 887117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2019
• 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: 66 YR
• Patient Sex: Female