BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY OTW

    MDR report key: 2953640 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01316
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE PROXIMAL AND DISTAL CONDUCTORS WERE NOTED TO HAVE BLOOD (NOT OBSTRUCTED). THE ANALYST COMMENTED THAT BY DESIGN, LEFT HEART LEADS ARE MANUFACTURED WITH A SEPTUM IN THE TIP THAT WILL SOMETIMES ALLOW BLOOD INGRESS.

    Additional Manufacturer Narrative · 1

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

    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: 2010 (B)(6); 5594 IMPLANTABLE PACING LEAD 2003 (B)(6); 6947 IMPLANTABLE DEFIB LEAD 2003 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION RELATED TO PACING IN THE LEFT VENTRICULAR LEAD. 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
    57791 ATTAIN ABILITY OTW DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R (B)(4) IMPLANTABLE BI-VENTRICULAR DEFIBRILLATOR