MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	4543
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were concerns of lead fracture for this left ventricular (lv) lead as it exhibited high out of range impedance measurements and failure to capture.Boston scientific technical services provided confirmation on the fracture.This lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that there were concerns of lead fracture for this left ventricular (lv) lead as it exhibited high out of range impedance measurements and failure to capture.Boston scientific technical services provided confirmation on the fracture.This lead remains in service.No adverse patient effects were reported.Additional information was received, this lead was explanted and successfully replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual inspection confirmed that the lead was returned in two segments severed approximately 260 mm from the terminal end.Visual inspection of the lead confirmed that the polyurethane insulation was damaged in two places.It was also noted that in multiple areas of the lead the coil was stretched.Detailed testing of the damaged insulation revealed the insulation in that area had become degraded at an accelerated rate, likely due to the patient's blood chemistry.The degradation then led to the observed damage.Subsequent testing noted both coils fractured located 60mm from the severed proximal end of the tip segment due to cyclic fatigue.
Event or Problem Description
It was reported that there were concerns of lead fracture for this left ventricular (lv) lead as it exhibited high out of range impedance measurements and failure to capture.Boston scientific technical services provided confirmation on the fracture.This lead remains in service.No adverse patient effects were reported.Additional information was received, this lead was explanted and successfully replaced.No additional adverse patient effects were reported.Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual inspection confirmed that the lead was returned in two segments severed approximately 260 mm from the terminal end.Visual inspection of the lead confirmed that the polyurethane insulation was damaged in two places.It was also noted that in multiple areas of the lead the coil was stretched.Detailed testing of the damaged insulation revealed the insulation in that area had become degraded at an accelerated rate, likely due to the patient's blood chemistry.The degradation then led to the observed damage.Subsequent testing noted both coils fractured located 60mm from the severed proximal end of the tip segment due to cyclic fatigue.

• Brand Name: EASYTRAK 2 IS-1
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17949645
• Report Number: 2124215-2023-57585
• Device Sequence Number: 7669688
• Product Code: NIK
• UDI-Device Identifier: 00802526579813
• UDI-Public: 00802526579813
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 192292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 02/09/2024; 04/12/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 02/14/2024; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female