BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3153452 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06009
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. CONCOMITANT PRODUCT: 4592 IMPLANTABLE PACING LEAD, (B)(6) 2011. A 6947 IMPLANTABLE TACHY LEAD, (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO HAVE DISLODGED AND WAS FLOATING IN THE ATRIUM. THE LV LEAD HAD NO CAPTURE IN ANY CONFIGURATION. THE LV LEAD WAS GOING TO BE REPOSITIONED BUT IT WAS NOT POSSIBLE TO ADVANCE A SHEATH OVER THE WIRE AND A VENOGRAM WAS PERFORMED WHICH SHOWED TWO STENOTIC AREAS IN THE SUBCLAVIAN VEIN. IT WAS DECIDED TO EXPLANT AND NOT REPLACE THE LV LEAD, AND PLACE A PIN PLUG IN THE LV PORT OF THE DEVICE INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256583 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR