MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; IMPLANTABLE LEAD

Model Number 4542

Device Problems Over-Sensing (1438); Pacing Problem (1439); Connection Problem (2900)

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

Event Date 01/03/2023

Event Type  Injury  

Event Description

It was reported that an alert was received through latitude due to right ventricular (rv) automatic threshold detected as greater than programmed amplitude or suspended.Upon further review, it was discussed that there is left ventricular (lv) oversensing, which results in inhibition of biventricular pacing.The patient is not pacemaker dependent.It was also mentioned that the alert received is due to fusion and intrinsic beat events, which is likely a result of the abnormal sensed events in the lv.Further in-clinic assessment was recommended as there is the possibility that the right atrial (ra) and lv leads are reversed in the device header, or the ra and lv leads position could be suboptimal.Troubleshooting suggestions were provided.In addition, the presenting electrogram (egm) continues to show atrio-ventricular desynchrony and there is no atrial capture.In-clinic testing was performed and the lead tests confirmed the atrial and left ventricular leads are likely reversed in the header.As a result, the device has been reprogrammed for the time being and the lead revision procedure has been scheduled.Lead revision was performed as scheduled and the lv and ra leads were adequately connected to the device header.The lead tests are showing appropriate measurements and the sensitivity was adjusted.The cardiac resynchronization therapy defibrillator (crt-d) system remains in service.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: IMPLANTABLE LEAD
• 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: 16196682
• MDR Text Key: 307613358
• Report Number: 2124215-2023-01882
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2013
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 147222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR