BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4161631 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11443
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING AND APPARENT EXPLANT DAMAGE.

    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 THAT THE LEAD EXHIBITED AN INSULATION DEFECT WHICH RESULTED IN DIAPHRAGMATIC/PHRENIC STIMULATION. IT WAS NOTED THAT THE LEAD APPEARED TO BE CUT. THE LEAD WAS PARTIALLY EXPLANTED AND THE DISTAL END REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640363 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R