BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3863120 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06549
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. PRODUCTS: 6947M55 LEAD IMPLANTED: 2013 -(B)(6); 407645 LEAD IMPLANTED: 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PHRENIC NERVE STIMULATION. IT WAS DETERMINED THAT THE RIGHT ATRIAL (RA) LEAD EXPERIENCED HIGH THRESHOLDS. THE RA LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED A FAILURE TO CAPTURE PRIOR TO EXPLANTATION. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339509 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R (B)(4) CRT-D