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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 Code High Capture Threshold (3266)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).At this time, the product has not been returned.If the product is returned and the analysis is performed, this report would be updated should pertinent information be provided.
 
Event or Problem Description
It was reported that this lead was capped due to high pacing threshold and due to the age of the lead.Lead was 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 Key9925163
Report Number2124215-2020-04927
Device Sequence Number3271781
Product Code NIK
UDI-Device Identifier00802526353772
UDI-Public00802526353772
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P010012/S025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/03/2020
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 Date08/05/2006
Device Model Number4525
Device Catalogue Number4525
Device Lot Number156766
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/05/2020
Initial Report FDA Received Date04/03/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age82 YR
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