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

Model Number 7841

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 04/11/2024

Event Type  Injury  

Event Description

It was reported that this patient presented to the clinic due to a right atrial (ra) lead repositioning procedure.It was noted that there was no p wave sensing and no capture from the pre procedure check and fluoroscopy confirmed that the lead had dialoged from its original implant location.The lead was successfully repositioned to the lateral atrial wall and all measurements were appropriate.No additional adverse patient effects were reported.

Event Description

It was reported that this patient presented to the clinic due to a right atrial (ra) lead repositioning procedure.It was noted that there was no p wave sensing and no capture from the pre procedure check, and fluoroscopy confirmed that the lead had dislodged from its original implant location.The lead was successfully repositioned to the lateral atrial wall and all measurements were appropriate.No additional adverse patient effects were reported.

Manufacturer Narrative

This report is being filed to update the implant date.

• Brand Name: INGEVITY+
• 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: 19102185
• MDR Text Key: 340100133
• Report Number: 2124215-2024-22426
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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: 1371179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention