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

Model Number 4543

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Failure to Read Input Signal (1581); High Capture Threshold (3266)

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

Event Date 11/20/2021

Event Type  Injury  

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead triggered alerts due to out of range intrinsic amplitude and high out-of-range pace impedance measurements greater than 3,000 ohms.In-clinic testing revealed variable lv pace impedances from 1,100 to >2,500 ohms.Lv thresholds also varied from.8v@0.5ms to non-capture at 6v@0.5ms.The lv lead was programmed to true bipolar, and it was noted that the patient was not pacer dependent.Noise was observed during isometric testing.The field representative was instructed to reprogram the lead from tip to can and check impedances and thresholds; pace impedances were consistently >2,500 ohms and threshold was 2.5v@0.5ms.Technical services (ts) discussed that this was likely a lead fracture with intermittent make-break connection that allowed for occasional in-range measurements.This lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead triggered alerts due to out of range intrinsic amplitude and high out-of-range pace impedance measurements greater than 3,000 ohms.In-clinic testing revealed variable lv pace impedances from 1,100 to >2,500 ohms.Lv thresholds also varied from.8v@0.5ms to non-capture at 6v@0.5ms.The lv lead was programmed to true bipolar, and it was noted that the patient was not pacer dependent.Noise was observed during isometric testing.The field representative was instructed to reprogram the lead from tip to can and check impedances and thresholds; pace impedances were consistently >2,500 ohms and threshold was 2.5v@0.5ms.Technical services (ts) discussed that this was likely a lead fracture with intermittent make-break connection that allowed for occasional in-range measurements.This lv lead remains in service.No adverse patient effects were reported.Additional information received reported that the patient was seen in clinic for further evaluation.A better vector was found lvring to rv, and consistent measurements were obtained in office and again via remote transmission.Rv pace impedance measurement was 685 ohms via a recent remote transmission.It was noted that autocapture was not on.This lv lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 triggered alerts due to out of range intrinsic amplitude and high out-of-range pace impedance measurements greater than 3,000 ohms.In-clinic testing revealed variable lv pace impedances from 1,100 to >2,500 ohms.Lv thresholds also varied from.8v@0.5ms to non-capture at 6v@0.5ms.The lv lead was programmed to true bipolar, and it was noted that the patient was not pacer dependent.Noise was observed during isometric testing.The field representative was instructed to reprogram the lead from tip to can and check impedances and thresholds; pace impedances were consistently >2,500 ohms and threshold was 2.5v@0.5ms.Technical services (ts) discussed that this was likely a lead fracture with intermittent make-break connection that allowed for occasional in-range measurements.This lv lead remains in service.No adverse patient effects were reported.Additional information received reported that the patient was seen in clinic for further evaluation.A better vector was found lvring to rv, and consistent measurements were obtained in office and again via remote transmission.Rv pace impedance measurement was 685 ohms via a recent remote transmission.It was noted that autocapture was not on.This lv lead remains in service.No adverse patient effects were reported.Additional information received reported that this left ventricular (lv) lead was explanted and replaced.It was noted that the cardiac resynchronization therapy defibrillator (crt-d) was also explanted and replaced during this procedure due to normal battery depletion (nbd).No additional adverse patient effects were reported.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13270331
• MDR Text Key: 284356058
• Report Number: 2124215-2022-00860
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2014
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 173348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/17/2022
• Supplement Dates Manufacturer Received: 12/21/2021; 10/26/2023
• Supplement Dates FDA Received: 01/26/2022; 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2012
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male