BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN CS

    MDR report key: 3160377 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08025
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. PRODUCT ID: (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) 2012 (B)(6); 5076-58 2003 (B)(6); (B)(4) COMPETITOR IMPLANTABLE PACING LEAD 2001 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS. THE LEFT VENTRICULAR (LV) LEAD, RIGHT VENTRICULAR (RV) LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259962 ATTAIN CS PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 2188-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R