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

Model Number	4543
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Asystole (4442)
Date of Event	05/21/2009
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
Boston scientific crm received information that this left ventricular (lv) lead was surgically abandoned three months post implant due to diaphragmatic stimulation.An epicardial lv lead was successfully implanted.Additional information received approximately 17 years later reported that lv lead was active in the patient's current cardiac resynchronization therapy pacemaker (crt-p) system.The patient presented to the hospital due to symptoms consistent with phrenic nerve stimulation (pns) described as small shocks and hiccup type sensations in the chest.A local field representative was paged for further evaluation.The following day, right atrial (ra) lead loss of capture (loc) was noted.Sinus arrest was suspected due to no sensing of p-waves with ra sensitivity at 0.15 mv.Additionally, there was intermittent left ventricular (lv) lead loc with a lv threshold measurement of 3.5 v @ 2.0 ms.Lv output was 3.5 v @ 2.0 ms, and all other vectors showed threshold measurements greater than 5 v.Ultimately, the physician chose to program the crt-p to vvir 60 beats per minute (bpm) and right ventricular (rv) only.Additional information received reported that sinus arrest was confirmed via underlying sensing testing and threshold testing.The patient was discharged on hospice, and later expired due to an unrelated patient condition (septic arthritis).

• 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: 24420875
• Report Number: 2124215-2026-09918
• Device Sequence Number: 17639304
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: (01)00802526410994(17)101204
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 02/23/2026

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: 12/04/2010
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 12/04/2008
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male