MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number 4457

Device Problems Failure to Capture (1081); Connection Problem (2900); High Capture Threshold (3266)

Patient Problem Unspecified Infection (1930)

Event Date 11/13/2021

Event Type  Injury  

Event Description

It was reported that two days following the device implant procedure, the right ventricular (rv) lead exhibited high, variable capture threshold measurements.There was some concern due to the patient's pacemaker dependency.At the one-week follow-up, the device was interrogated and there were multiple instances of loss of capture (loc) accompanied by coughing from the patient.The physician performed threshold testing which also elicited coughing.The patient indicated that since the device change procedure, he had been coughing more and feeling light-headed, which impacted physical activity.Additionally, the device wound pocket was still bleeding, which caused the physician cause for concern regarding a potential infection.The following day, the physician elected to perform a rv revision procedure.A fluoroscopy was performed which confirmed the rv lead was not inserted completely into the device header.The lead was disconnected from the device and tested using a pacemaker system analyzer which still demonstrated high capture threshold measurements.Due to the patient's dependency, the physician elected to surgically cap and abandon the rv lead.A new rv lead was subsequently implanted to resolve the event.At this time, the device remains implanted and in-service.The previous rv lead remains implanted, but capped and out-of-service.The patient was stable with no additional adverse effects.

• Brand Name: FINELINE II STEROX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 13386529
• MDR Text Key: 284640838
• Report Number: 2124215-2021-40507
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: 00802526060915
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2014
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 726067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 41 YR