MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2; IMPLANTABLE LEAD

Model Number	4518
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) and requested a review of the presenting electrogram (egm) of this cardiac resynchronization therapy defibrillator (crt-d) system due to concerns of loss of capture (loc) on the left ventricular (lv) lead.Upon review, the presenting egm showed that the lv appeared to be intermittently exhibit loc.Ts recommended for the hcp to schedule the patient for an in-office visit to further evaluate the lead.At this time, the lv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) and requested a review of the presenting electrogram (egm) of this cardiac resynchronization therapy defibrillator (crt-d) system due to concerns of loss of capture (loc) on the left ventricular (lv) lead.Upon review, the presenting egm showed that the lv appeared to be intermittently exhibit loc and high pacing thresholds.Ts recommended for the hcp to schedule the patient for an in-office visit to further evaluate the lead.At this time, the lv lead remains in service.No adverse patient effects were reported.

• Brand Name: EASYTRAK 2
• Common Device Name: IMPLANTABLE LEAD
• 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 ; * 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20113102
• Report Number: 2124215-2024-54537
• Device Sequence Number: 15291119
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: 00802526417672
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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
• Report Date (Section B): 09/24/2024

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: 09/20/2008
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/24/2024
• Date Device Manufactured: 09/20/2006
• 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: 65 YR
• Patient Sex: Female