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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number 4525
Medical Device Problem Codes High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/23/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited high pacing threshold measurements and high out of range pacing impedance measurements greater than 2,000 ohms.Surgical intervention was undertaken.The lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
 
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Brand Name
EASYTRAK 3
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11729854
Report Number2124215-2021-10229
Device Sequence Number3193084
Product Code NIK
UDI-Device Identifier00802526353772
UDI-Public00802526353772
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P010012/S025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/26/2021
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 Date09/29/2007
Device Model Number4525
Device Catalogue Number4525
Device Lot Number159490
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/23/2021
Initial Report FDA Received Date04/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age81 YR
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