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

Model Number	4544
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited no capture in any lv configuration and high out-of-range pace impedance measurements greater than 2,500 ohms.Lv lead fracture was suspected.This lv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
As of today, this lead remains implanted and has not been returned.As such, physical analysis has not been conducted in our laboratory.However, investigation was completed and it was determined that the reported clinical observations are known inherent risks as described in the instructions for use manual for this model lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited no capture in any lv configuration and high out-of-range pace impedance measurements greater than 2,500 ohms.Lv lead fracture was suspected.This lv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.

• 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
• MDR Report Key: 11356333
• Report Number: 2124215-2021-03926
• Device Sequence Number: 790722
• Product Code: NIK
• UDI-Device Identifier: 00802526579820
• UDI-Public: 00802526579820
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2021

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: 08/16/2015
• Device Model Number: 4544
• Device Catalogue Number: 4544
• Device Lot Number: 102576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/20/2021
• Supplement Report FDA Received Date: 04/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR