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

Model Number 7842

Device Problems Failure to Capture (1081); High impedance (1291); Mechanical Problem (1384); Off-Label Use (1494); Failure to Read Input Signal (1581); Positioning Problem (3009); High Capture Threshold (3266)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

This lead is expected to be returned and analyzed.A supplemental report will be filed upon completion.

Event Description

It was reported that this lead was an attempted implant into the left bundle branch (lbb) position in the right ventricular (rv) septum, which is considered off label use.This lead was the second attempted lbb lead within this procedure.The following clinical observations were observed; difficulty in positioning, unable to obtain good morphology, pace impedance measurements of greater than 2000 ohms, high threshold measurement and non capture at 5 volts.The helix was extended and captured at 10 volts however were unable to get impedance lower after attempting to extend the helix further.The helix was retracted and removed from body.It was confirmed via fluoroscopy that the helix was fully extended.A third and final lead was attempted which was successfully implanted.No adverse patient effects were reported.

Event Description

It was reported that this lead was an attempted implant into the left bundle branch (lbb) position in the right ventricular (rv) septum, which is considered off label use.This lead was the second attempted lbb lead within this procedure.The following clinical observations were observed; difficulty in positioning, unable to obtain good morphology, pace impedance measurements of greater than 2000 ohms, high threshold measurement and non capture at 5 volts.The helix was extended and captured at 10 volts however were unable to get impedance lower after attempting to extend the helix further.The helix was retracted and removed from body.It was confirmed via fluoroscopy that the helix was fully extended.A third and final lead was attempted which was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

Correction to removing code 2699.

• 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: 18943392
• MDR Text Key: 338357834
• Report Number: 2124215-2024-16964
• 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: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 1230194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2023
• 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: 68 YR
• Patient Sex: Female