BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 4162819 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12597
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PRODUCTS: 4574-45 LEAD, IMPLANTED: (B)(6) 2005; A 6947-58 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH THRESHOLDS WERE OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. DURING EXTRACTION, THE PHYSICIAN ATTEMPTED TO REMOVE THE LV LEAD, HOWEVER, WAS UNSUCCESSFUL DUE TO THE TIP GETTING STUCK IN THE PATIENT'S CORONARY SINUS. THE LV LEAD WAS CUT, CAPPED, AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640249 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419378

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R C154DWK ICD