BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 2813640 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16782
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    December 16, 2004
    Report Date
    January 15, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY OF IMPLANT, THE PATIENT HAD PHRENIC NERVE STIMULATION. THE PHYSICIAN INDICATED THAT THE STIMULATION WAS PROCEDURE RELATED. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPILATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention