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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); Fracture (1260); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  Injury  
Event Description
It was reported that this left ventricular (lv) lead exhibited pace impedance measurements of greater then 3,000 ohms and loss of capture.It was noted that the lead was likely fractured.A lead revision procedure was performed in which the lv lead was explanted.A new lead was implanted and remains in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection confirmed the lead was severed -12.5 cm from the terminal end.A facture of all conductors was observed -35 cm from the terminal end.
 
Event Description
It was reported that this left ventricular (lv) lead exhibited pace impedance measurements of greater then 3,000 ohms and loss of capture.It was noted that the lead was likely fractured.A lead revision procedure was performed in which the lv lead was explanted.A new lead was implanted and remains in service.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
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 Key15371076
MDR Text Key299384659
Report Number2124215-2022-34671
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 Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/31/2022
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 Date02/23/2013
Device Model Number4542
Device Catalogue Number4542
Device Lot Number146206
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2022
Initial Date FDA Received09/07/2022
Supplement Dates Manufacturer Received10/21/2022
Supplement Dates FDA Received10/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2011
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 Outcome(s) Hospitalization; Required Intervention;
Patient Age54 YR
Patient SexFemale
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