BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 3153505 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06064
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 A CUT. IT WAS NOTED THAT THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE INNER TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT DUE TO THE SUBSTANTIAL AMOUNT OF BLOOD INGRESS AND THE SHORTED CONDITION OF THE CONDUCTORS, IT IS LIKELY THAT THE DAMAGE TO THE INSULATION OCCURRED DURING THE INITIAL IMPLANT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 1346T COMPETITOR IMPLANTABLE PACING LEAD: (B)(6) 1998. 1388T COMPETITOR IMPLANTABLE PACING LEAD: (B)(6) 1998. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD THERE WAS NOTED HIGH THRESHOLDS AS WELL AS DIAPHRAGMATIC STIMULATION. THEREFORE THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256695 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R C4TR01 IMPLANTABLE PACEMAKER CARDIO/DEFIB