BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3990037 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08830
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THAT THE LEFT VENTRICULAR LEAD IMPEDANCE BEGINS RISING FROM AN APPROXIMATE BASELINE OF 850 OHMS STARTING (B)(6) 2014. THE LEFT VENTRICULAR LEAD IMPEDANCE RISES UP TO GREATER THAN 1500 OHMS BY (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 5076 X 2 LEADS, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAS HAD AN INCREASE IN IMPEDANCE AND IS NOW HIGH. THE THRESHOLD HAS ALSO INCREASED. THIS HAS LED TO A LOSS OF LEFT RESYNCHRONIZATION. THE LEAD REMAINS IN USE AND A REVISION WILL BE DISCUSSED WITH THE PHYSICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465113 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR C3TR01 ICD