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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 3; IMPLANTABLE LEAD
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CPI - DEL CARIBE EASYTRAK 3; IMPLANTABLE LEAD Back to Search Results
Model Number 4550
Medical Device Problem Codes Pacing Problem (1439); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/12/2016
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 had dislodged.There was pacing therapy that was not delivered when required.An invasive procedure was performed to explant and replace the lead.No adverse patient effects were reported.
 
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Brand Name
EASYTRAK 3
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
MDR Report Key5795510
Report Number2124215-2016-10762
Device Sequence Number657383
Product Code LWP
UDI-Device Identifier00802526420511
UDI-Public(01)00802526420511(17)20150418
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/13/2016
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 Date04/18/2015
Device Model Number4550
Other Device ID NumberEASYTRAK 3
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 06/13/2016
Initial Report FDA Received Date07/14/2016
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
4473
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age47 YR
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