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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 2; IMPLANTABLE LEAD
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CPI - DEL CARIBE EASYTRAK 2; IMPLANTABLE LEAD Back to Search Results
Model Number 4542
Medical Device Problem Codes Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/25/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lead has not been returned at this time.If the device is returned, analysis will be performed and this report will be updated.
 
Event or Problem Description
Boston scientific received information that this left ventricular (lv) lead exhibited high pacing threshold measurements and dislodgement.The lead was subsequently explanted and replaced.No additional adverse patient effects were reported.
 
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Brand Name
EASYTRAK 2
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
MDR Report Key7650559
Report Number2124215-2018-11718
Device Sequence Number16598781
Product Code NIK
UDI-Device Identifier00802526579806
UDI-Public00802526579806
Combination Product (Y/N)N
Initial Reporter StatePR
Initial Reporter CountryUS
PMA/510(K) Number
P010012/S024
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/25/2018
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 Date03/30/2017
Device Model Number4542
Other Device ID NumberEASYTRAK 2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2018
Initial Report FDA Received Date06/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
0295; 4470; 4542; G150
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age75 YR
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