BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3152362 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06839
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 MEDICAL PRODUCTS: 6947M, IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2012; 5076, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012.  (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S RELATIVE THAT THE LEFT VENTRICULAR (LV) LEAD HAD MOVED UP INTO THE PATIENT¿S SHOULDER AREA AND WAS CAUSING THE PATIENT¿S ARM TO JUMP. 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
    252991 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR