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

Model Number 7732

Device Problem Difficult to Insert (1316)

Patient Problem Asystole (4442)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that during a device change out procedure, when connecting this right ventricular (rv) lead to the new pacemaker, insertion issues occurred.This rv lead was difficult to insert into the port of the related pacemaker.The physician described that he could not see the lead past the connector block.The port had been vented and the physician unscrewed the set screw as far as possible, and tried to push the lead in, which was unsuccessful.The rv lead was then removed from the port, which led to a period of asystole, and the lead was reinserted into the port.The physician then proceeded to pull on the rv lead to ensure that it was secure, and the lead was unable to come out, therefore, the lead was fixed in place by the set screw.It was noted that the thresholds and impedances were normal during the post op check.No additional adverse patient effects were reported.This pacemaker and the related lead remain implanted and in service.

Event Description

It was reported that during a device change out procedure, when connecting this right ventricular (rv) lead to the new pacemaker, insertion issues occurred.This rv lead was difficult to insert into the port of the related pacemaker.The physician described that he could not see the lead past the connector block.The port had been vented and the physician unscrewed the set screw as far as possible, and tried to push the lead in, which was unsuccessful.The rv lead was then removed from the port, which led to a period of asystole, and the lead was reinserted into the port.The physician then proceeded to pull on the rv lead to ensure that it was secure, and the lead was unable to come out, therefore, the lead was fixed in place by the set screw.It was noted that the thresholds and impedances were normal during the post op check.No additional adverse patient effects were reported.This pacemaker and the related lead remain implanted and in service.Additional information: a good faith effort was submitted to the field to obtain further information as to how long the period of asystole lasted.The field representative was unable to provide this information as they were not present during the procedure.

Manufacturer Narrative

This additional/correction report is being submitted to include additional information that has been added to section b (b5), event description.Additionally, the line of coding for more complex surgery (f1907) has been removed from section h (h6), impact codes as recommended by our medical review team.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16901933
• MDR Text Key: 314899762
• Report Number: 2124215-2023-22940
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526523335
• UDI-Public: 00802526523335
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2017
• Device Model Number: 7732
• Device Catalogue Number: 7732
• Device Lot Number: 628378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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: 79 YR
• Patient Sex: Male