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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 Failure to Capture (1081); Device Dislodged or Dislocated (2923); Impedance Problem (2950)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/20/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This lead has not been returned for analysis.Should additional information become available, or if analysis is completed, this report will be updated.
 
Event or Problem Description
Boston scientific received information that during routine follow-up, this left ventricular (lv) lead exhibited impedance measurement anomalies as well as loss of capture.It was determined the lead had dislodged.An invasive procedure was performed.The lead was 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 Key6475803
Report Number2124215-2017-01141
Device Sequence Number16443747
Product Code NIK
UDI-Device Identifier00802526579806
UDI-Public(01)00802526579806(17)20170512
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/12/2017
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 Date05/12/2017
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 01/12/2017
Initial Report FDA Received Date04/10/2017
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; 4479; 4542; N160
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age70 YR
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