BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 3051858 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04930
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    June 15, 2004
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC, INC
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT ID 7279, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2004. PRODUCT ID 6932, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152174 ATTAIN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R