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

Model Number	4542
Medical Device Problem Codes	Use of Device Problem (1670); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that interrogation of this cardiac resynchronization therapy defibrillator (crt-d) system was unsuccessful, and this crt-d had reached the explant indicator in (b)(6) 2024.Review of device settings noted low out-of-range pace impedance measurements less than 200 ohms for more than a year on the right ventricular (rv) lead, which was purposefully connected to the left ventricular (lv) port at the last device replacement procedure.Additional information received reported that the rv lead impedance issue was known at the previous device changeout, and the rv and lv leads were purposefully switched in the header during the battery replacement procedure for this reason.At this time, there are no other plans for intervention, other than the upcoming battery replacement.This lv lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.Correction to b2: populated outcomes attrib to adv event.
Event or Problem Description
It was reported that interrogation of this cardiac resynchronization therapy defibrillator (crt-d) system was unsuccessful, and this crt-d had reached the explant indicator in october 2024.Review of device settings noted low out-of-range pace impedance measurements less than 200 ohms for more than a year on the right ventricular (rv) lead, which was purposefully connected to the left ventricular (lv) port at the last device replacement procedure.Additional information received reported that the rv lead impedance issue was known at the previous device changeout, and the rv and lv leads were purposefully switched in the header during the battery replacement procedure for this reason.At this time, there are no other plans for intervention, other than the upcoming battery replacement.This lv lead remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that interrogation of this cardiac resynchronization therapy defibrillator (crt-d) system was unsuccessful, and this crt-d had reached the explant indicator in october 2024.Review of device settings noted low out-of-range pace impedance measurements less than 200 ohms for more than a year on the right ventricular (rv) lead, which was purposefully connected to the left ventricular (lv) port at the last device replacement procedure.Additional information received reported that the rv lead impedance issue was known at the previous device changeout, and the rv and lv leads were purposefully switched in the header during the battery replacement procedure for this reason.At this time, there are no other plans for intervention, other than the upcoming battery replacement.This lv lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.Correction to b2: populated outcomes attrib to adv event.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of labeling determined that the complaint situation was listed in the manual.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.

• 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): 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: 24537246
• Report Number: 2124215-2026-12713
• Device Sequence Number: 15710084
• Product Code: NIK
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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: 02/14/2010
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 03/09/2026; 06/15/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/11/2026; 06/16/2026
• Date Device Manufactured: 02/14/2008
• 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