BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3863409 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06734
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MEDICAL PRODUCTS: 6947M62 LEAD, (B)(6) 2014; DTBA1D4 ICD, (B)(6) 2014; 694765 LEAD, (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS WERE EXPLANTED. A TEMPORARY LEAD WAS PLACED AND ATTACHED TO AN EXTERNAL PACEMAKER AS THE PATIENT IS PACEMAKER DEPENDENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339115 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 5076-52 LEAD