MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	4517
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Codes	Dyspnea (1816); Swelling/ Edema (4577)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient attended clinic for a routine follow-up appointment, and indicated hearing beeping tones coming from the related pulse generator (pg).During device interrogation, it was found that the pg had reached elective replacement indicator (eri) as expected.Unexpectedly, it appeared that this this left ventricular (lv) lead had a suspected fracture because it was not capturing on presentation.The patient also indicated that he was experiencing shortness of breath, and that his legs had become more swollen.The lead trend graph showed a change in impedance measurements, which were high and out of range.The lv lead configurations were tested, confirming that the impedances were greater than 2500 ohms, and high capture thresholds were also observed.Since the patient had good underlying rhythm, the physician elected to reprogram device settings.The patient has been scheduled for routine replacement of the related pg; therefore, it is intended that this lead will be replaced at the same time.This lead remains implanted and in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient attended clinic for a routine follow-up appointment, and indicated hearing beeping tones coming from the related pulse generator (pg).During device interrogation, it was found that the pg had reached elective replacement indicator (eri) as expected.Unexpectedly, it appeared that this this left ventricular (lv) lead had a suspected fracture because it was not capturing on presentation.The patient also indicated that he was experiencing shortness of breath, and that his legs had become more swollen.The lead trend graph showed a change in impedance measurements, which were high and out of range.The lv lead configurations were tested, confirming that the impedances were greater than 2500 ohms, and high capture thresholds were also observed.Since the patient had good underlying rhythm, the physician elected to reprogram device settings.The patient has been scheduled for routine replacement of the related pg; therefore, it is intended that this lead will be replaced at the same time.This lead remains implanted and in service.No adverse patient effects were reported.A follow-up email was sent to the field to obtain further information regarding the status of the lead.No further information was able to be provided.
Additional 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.

• Brand Name: EASYTRAK 2
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 14048940
• Report Number: 2124215-2022-03753
• Device Sequence Number: 5995092
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/21/2008
• Device Model Number: 4517
• Device Catalogue Number: 4517
• Device Lot Number: 424711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Unknown