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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK; IMPLANTABLE LEAD

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CPI - DEL CARIBE EASYTRAK; IMPLANTABLE LEAD Back to Search Results
Model Number 4513
Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Perforation (2001); Pocket Erosion (2013)
Event Date 04/20/2018
Event Type  Injury  
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 Description
Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection and erosion.Reportedly, the device was infected with the lead perforation through the skin and open wound.The patient was given intravenous antibiotics preoperatively.The device pocket was debrided and cauterized for potential bleeding sites.The wound was then debrided and irrigated with antibiotic saline solution.There were no additional adverse patient effects reported.The lv lead was explanted.
 
Event Description
Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection and erosion.The patient was given intravenous antibiotics preoperatively.The device pocket was debrided and cauterized for potential bleeding sites.The wound was then debrided and irrigated with antibiotic saline solution.The lv lead was explanted.No additional adverse patient effects were reported.
 
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Brand Name
EASYTRAK
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
Manufacturer (Section G)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
Manufacturer Contact
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7622586
MDR Text Key111819982
Report Number2124215-2018-09604
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
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 04/23/2018
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
Device Operator Lay User/Patient
Device Expiration Date07/13/2003
Device Model Number4513
Other Device ID NumberEASYTRAK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/23/2018
Initial Date FDA Received06/20/2018
Supplement Dates Manufacturer Received04/23/2018
Supplement Dates FDA Received07/04/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/13/2001
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; Life Threatening; Required Intervention;
Patient Age86 YR
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