BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3152703 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06702
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    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: C2TR01, IMPLANTABLE PULSE GENERATOR, (B)(6) 2013; 5076-52, IMPLANTABLE PACING LEAD, (B)(6) 2013; 5076-45, IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS TOO SUPPLE AND KEPT MOVING IN THE LATERAL VEIN. THE PHYSICIAN DECIDED TO REPLACE THE LEAD WITH A COMPETITOR PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252242 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Hospitalization| R