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

Model Number	4517
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, a supplemental report will be provided.
Event or Problem Description
It was reported that this left ventricular (lv) lead showed high, out of range pacing impedances for most part of the year.The value is consistently high.The lv lead sensing had been programmed off.There were no related cases to say why these changes were made.Boston scientific technical services discussed with the caller design characteristics and mentioned the possibility an issue through conductors due to the impedance measurement behavior.No changes were recommended at this time as it was unknown why the device had been programmed the way it was in the past.The lv lead remains in service at this time.No adverse patient effects were reported.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16018737
• Report Number: 2124215-2022-53976
• Device Sequence Number: 6894306
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 01/18/2012
• Device Model Number: 4517
• Device Catalogue Number: 4517
• Device Lot Number: 437062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2010
• 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: 77 YR
• Patient Sex: Female