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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 4543
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/17/2018
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The lv lead was explanted.
 
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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 Key7990222
Report Number2124215-2018-16503
Device Sequence Number1487949
Product Code NIK
UDI-Device Identifier00802526579813
UDI-Public00802526579813
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P010012/S024
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/19/2018
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? No
Operator of Device Lay User/Patient
Device Expiration Date03/26/2017
Device Model Number4543
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 08/19/2018
Initial Report FDA Received Date10/22/2018
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
0283; 4136; 4543; 7742; G140
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age56 YR
Patient Weight91
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