BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3741485 · Received April 11, 2014

    Report

    Report Number
    2649622-2014-02966
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 6, 2014
    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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    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 MEDICAL PRODUCTS: PRODUCT ID: D224TRK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, IMPLANTED: (B)(6) 2014. PRODUCT ID: A 694458 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6).2014. PRODUCT ID: A 507645 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVELY, THE LEFT VENTRICULAR (LV) LEAD EXPERIENCED LOSS OF CAPTURE DUE TO THE LV LEAD PULLING BACK AND BECOMING DISLODGED DUE TO DIFFICULT ANATOMY. THE LV LEAD WAS EXPLANTED AND A NEW LEAD PLACED SUCCESSFULLY IN A DIFFERENT VEIN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224646 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 305C225 TISSUE VALVE