BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3153348 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05964
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THAT THERE WAS BLOOD NOTED ON THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD AND IT WAS NOT OBSTRUCTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR TO SIX WEEKS AFTER THE IMPLANT OF THE LEFT VENTRICULAR LEAD IT WAS FOUND TO BE DISLODGED. INCREASED THRESHOLDS, LOSS OF CAPTURE AND INTERMITTENT DIAPHRAGMATIC STIMULATION WERE ALSO REPORTED. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255329 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R D204TRM BI-VENTRICULAR DEFIBRILLATOR