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 FINELINE II; 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 FINELINE II; IMPLANTABLE LEAD Back to Search Results
Model Number 4458
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 01/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The root cause of the reported clinical observations was not identified and efforts to obtain additional product issue details were unsuccessful.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 patient went to the emergency room due to a heart rate of 32bpm.The patient also had been experiencing soreness at the implant site.The device was not interrogated at the hospital and the patient was scheduled for a device checked the day of this call.The patient stated he had been told that he had a loose wire which will need replacement.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FINELINE II
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
MDR Report Key7350496
Report Number2124215-2018-03038
Device Sequence Number952528
Product Code DTB
UDI-Device Identifier00802526060953
UDI-Public00802526060953
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P960004/S014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date10/01/2014
Device Model Number4458
Other Device ID NumberFINELINE II STEROX
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 01/12/2018
Initial Report FDA Received Date03/19/2018
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
4458; K063; MISMATCH
-
-