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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 Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this left ventricular (lv) lead was found out to be fractured.Additional information obtained from the field which indicated that this lead also exhibited high impedance measurements.The lead was surgically abandoned.No additional adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.The complaint device was not returned by the customer; therefore, no product analysis could be performed.The information provided was not sufficient to allow determination of probable cause.Lead conductor coil fracture is listed as a potential adverse event in the physician's lead manual.Therefore, no further actions are considered necessary and the complaint investigation conclusion code is known inherent risk of device.
 
Event Description
It was reported that this left ventricular (lv) lead was found out to be fractured.Additional information obtained from the field which indicated that this lead also exhibited high impedance measurements.The lead was surgically abandoned.No additional adverse patient effects were reported.
 
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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
MDR Report Key8852510
MDR Text Key152996883
Report Number2124215-2019-15440
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526410901
UDI-Public00802526410901
Combination Product (y/n)N
PMA/PMN Number
P010012/S024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/05/2019
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 Date08/25/2011
Device Model Number4542
Device Catalogue Number4542
Device Lot Number135598
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/18/2019
Initial Date FDA Received08/01/2019
Supplement Dates Manufacturer Received08/26/2019
Supplement Dates FDA Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age54 YR
Patient Weight109
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