BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3051032 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04766
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    June 26, 2012
    Report Date
    January 11, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT: 6931 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2006; D234TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WOULD ONLY CAPTURE AT HIGH THRESHOLDS. THE LEAD WAS EXPLANTED 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
    153348 ATTAIN OTW ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R