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

Model Number 4542

Device Problems Failure to Capture (1081); High impedance (1291); Connection Problem (2900)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead showed loss of capture (loc) on the presenting electrogram (egm).In addition, there were multiple high out-of-range pace impedance spikes greater than 3,000 ohms, and it was suspected that the lead-to-head connection was the cause.Technical services (ts) recommended evaluating pace vectors that did not use the ring.Additional information received reported that the patient experienced phrenic nerve stimulation in every other configuration, which is why this vector had been chosen.Thresholds taken that day were 1.5v and output was set to 2v; the safety margin was later increased and trend was programmed on.A twelve lead echocardiogram (ecg) was taken, and capture was confirmed.This crt-d system remains in service and will continue to be monitored.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): 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: 15739483
• MDR Text Key: 306187671
• Report Number: 2124215-2022-45484
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2007
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female