BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 4161158 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11625
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. CONCOMITANT PRODUCT: 694958 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THEIR DEVICE TONING AND PRESENTED TO THE CLINIC. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR (RV) PACE/SENSE PORTION, HOWEVER, THE LEFT VENTRICULAR (LV) LEAD IS THE LEAD THAT IS PLUGGED INTO THE RV PACE/SENSE PORT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637930 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR D274TRK ICD