BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3071706 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05242
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 5554 IMPLANTABLE PACING LEAD 2006 (B)(6); 6948 IMPLANTABLE TACHY LEAD 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING NON-CAPTURE POST-IMPLANT. A CHEST X-RAY CONFIRMED THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171606 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR