BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3153441 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06019
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    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 AND 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 PRODUCT: 693065 IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS ENROLLED IN THE SYSTEMS LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257269 ATTAIN OTW DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R N141 COMPETITOR IMPLANTABLE CARDIOVERTER DEFIB