BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3050938 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04805
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 2, 2011
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4): PRODUCT ID D284TRK IMPLANTED: 2010-(B)(6); PRODUCT ID 5076-52, IMPLANTED: 2010-(B)(6); PRODUCT ID 694765, IMPLANTED: 2010-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT IN THE CLINICAL SERVICE STUDY WAS HOSPITALIZED DUE TO A POCKET INFECTION. THE LEAD WAS EXTRACTED AT ANOTHER HOSPITAL. THE PHYSICIAN HAD NO COMPLAINT WITH THE PRODUCT. THE LEAD WILL NOT BE RETURNED TO THE MANUFACTURER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149759 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R