BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN LV

    MDR report key: 5408611 · Received February 3, 2016

    Report

    Report Number
    2649622-2016-00218
    Event Type
    Injury
    Date Received
    February 3, 2016
    Date of Event
    October 25, 2004
    Report Date
    June 26, 2006
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 432-35S-45 LEAD, IMPLANTED: (B)(6) 2001; 430-35S-52 LEAD, IMPLANTED: (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXPERIENCED ELEVATED THRESHOLD AND PACING FAILURE GRADUALLY DEVELOPED. THE LV LEAD WAS MONITORED AND SUBSEQUENTLY REPLACED DURING A ROUTINE GENERATOR CHANGE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66948 ATTAIN LV PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 2187

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R