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

Model Number 4543

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Pacing Problem (1439); Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2023

Event Type  malfunction  

Event Description

It was reported that this left ventricular (lv) lead exhibited high out of range pacing impedance measurements greater than 2,000 ohms.Additionally, review of stored episodes noted pacing inhibition on the lv channel due to a morphology difference when there is biventricular pacing, right ventricular (rv) only pacing, or intrinsic.Technical services (ts) recommended in-clinic assessment.The local field representative indicated that the patient was scheduled for in clinic evaluation on a future date.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this left ventricular (lv) lead exhibited high out of range pacing impedance measurements greater than 2,000 ohms.Additionally, review of stored episodes noted pacing inhibition on the lv channel due to a morphology difference when there is biventricular pacing, right ventricular (rv) only pacing, or intrinsic.Technical services (ts) recommended in-clinic assessment.The local field representative indicated that the patient was scheduled for in clinic evaluation on a future date.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If pertinent information is provided in the future, a supplemental report will be submitted.It was reported that the patient was seen in clinic for evaluation.The lv lead exhibited loss of capture (loc) with no other viable programming vectors available.A lead fracture was suspected.The lead was programmed off and the patient was referred for lead replacement.No adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17252678
• MDR Text Key: 318452113
• Report Number: 2124215-2023-34584
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/13/2007
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 110976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male