BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX PENTA CORONARY STENT SYSTEM

    MDR report key: 385061 · Received March 22, 2002

    Report

    Report Number
    2024168-2002-00100
    Event Type
    Malfunction
    Date Received
    March 22, 2002
    Date of Event
    December 24, 2001
    Report Date
    March 1, 2002
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LETTER FROM THE FDA THAT WAS RECEIVED 03/2002 THAT A USER FACILITY MEDWATACH REPORT WAS SUBMITTED TO THE OFFICE IN 01/2002. GUIDANT LEARNED OF POSSIBLE CONTAMINATION OF THIS PRODUCT AND NOTIFIED THE HOSPITAL'S NOTIFICATION. ADDITIONAL FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THE PATIENT HAD A FEVER POST IMPLANTATION. THE ACCOUNT REPORTED THAT THE FEVER WAS NOT BELIEVED TO BE CAUSED BY THE STENT, HOWEVER GUIDANT WILL CONSERVATIVELY FILE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX PENTA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 1112031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN