BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3071669 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05253
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2010 (B)(6); 6949 IMPLANTABLE TACHY LEAD 2006 (B)(6); 5076 IMPLANTABLE PACING LEAD 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYSTEM CHANGE OUT PROCEDURE THE RIGHT ATRIAL LEAD WAS DAMAGED, THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. IT WAS ALSO REPORTED THAT THERE WERE HIGH THRESHOLDS IN THE LEFT VENTRICULAR (LV) LEAD. THE LV 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
    171802 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R