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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); Pacing Problem (1439); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2019
Event Type  Injury  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
Boston scientific received information that this left ventricular (lv) lead was explanted due to pacing not delivered when required, high pacing impedance that was greater than 2000 ohms, loss of capture and lead conductor fracture.No additional adverse patient effects were reported.
 
Event Description
Boston scientific received information that this left ventricular (lv) lead was explanted due to pacing not delivered when required, high pacing impedance that was greater than 2000 ohms, loss of capture and lead conductor fracture.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an evaluation of this lead was performed.Complete lead returned severed into two segments.The failure-to-capture, high impedance, pacing not delivered and conductor damage allegations were confirmed.X-ray inspection showed both anode and cathode conductors were fractured at the distal end of the suture sleeve tie-down.Setscrew mark noted in correct location.
 
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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 Key8597585
MDR Text Key144658997
Report Number2124215-2019-09812
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 08/08/2019
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 Date06/01/2013
Device Model Number4542
Device Catalogue Number4542
Device Lot Number147857
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received05/09/2019
Supplement Dates Manufacturer Received06/28/2019
Supplement Dates FDA Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age50 YR
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