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 Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited a high out of range pacing impedance measurements of greater than 2000 ohms.This measurement coincided with a time in which the patient had reported experiencing a fall.No changes have been made and the lv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited a high out of range pacing impedance measurements of greater than 2000 ohms.This measurement coincided with a time in which the patient had reported experiencing a fall.No changes have been made and the lv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14068821
• Report Number: 2124215-2022-08191
• Device Sequence Number: 11993209
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• 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): 05/21/2022

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: 01/27/2005
• Device Model Number: 4517
• Device Catalogue Number: 4517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/09/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown