BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3861637 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07216
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO PULLING/STRETCHING/OVERSTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE OUTER INSULATION DISCONNECTED FROM THE DISTAL END OF THE LEAD PIN INSULATION EXPOSING INNER CONDUCTORS. IT WAS NOTED THAT NO PRESSURE/PULLING WAS APPLIED TO THE LEAD TO CAUSE THIS ISSUE. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339691 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1