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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number 4542
Device Problems Failure to Capture (1081); High impedance (1291)
Patient Problems Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
If additional information is received, a supplemental report will be filed at that time.
 
Event Description
It was reported that this left ventricular (lv) lead exhibited pace impedance measurement of greater than 2,000 ohms and loss of capture.The patient was brought in and the lead was tested and everything looked fine.The field representative would continue to monitor closely.The lead remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this left ventricular (lv) lead exhibited pace impedance measurement of greater than 2,000 ohms and loss of capture.The patient was brought in and the lead was tested and everything looked fine.The field representative would continue to monitor closely.The lead remains in service.No adverse patient effects were reported.Additional information was received that lv lead testing was performed which produced high thresholds and pace impedance measurements of greater than 3,000 ohms.It was noted that the patient experienced stimulation.Boston scientific technical services discussed continuing to monitor with the field representative.No adverse patient effects were reported.
 
Manufacturer Narrative
If additional information is received, a supplemental report will be filed at that time.
 
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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 Key12661403
MDR Text Key277368954
Report Number2124215-2021-30361
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526410901
UDI-Public00802526410901
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P010012/S024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/14/2017
Device Model Number4542
Device Catalogue Number4542
Device Lot Number164907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
Patient SexFemale
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