Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 3; IMPLANTABLE LEAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CPI - DEL CARIBE EASYTRAK 3; IMPLANTABLE LEAD Back to Search Results
Model Number 4524
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/17/2018
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 the patient with this left ventricular (lv) lead had an infection and a system extraction was planned.There were no additional adverse patient effects reported.The lv lead remains in service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EASYTRAK 3
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
MDR Report Key7648377
Report Number2124215-2018-11324
Device Sequence Number19245548
Product Code NIK
UDI-Device Identifier00802526353758
UDI-Public00802526353758
Combination Product (Y/N)N
PMA/510(K) Number
P010012/S025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/17/2018
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 Date12/17/2011
Device Model Number4524
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 05/17/2018
Initial Report FDA Received Date06/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age88 YR
-
-