BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2203700 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11725
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE FIRST LEFT VENTRICULAR LEAD ATTEMPT COULD NOT GET INTO THE TARGET VESSEL AND THEN WHEN THE PHYSICIAN TRIED TO INTRODUCE THE INNER SHEATH HE DROPPED IT ON THE FLOOR. THIS LEAD WAS THEN REPLACED WITH THE ATTEMPT OF A NEW LEFT VENTRICULAR LEAD; HOWEVER THE PHYSICIAN COULD NOT GET SATISFACTORY NUMBERS AT ANY LOCATION AFTER ATTEMPTING MULTIPLE VESSELS. THE PHYSICIAN THEN REMOVED THIS SECOND LEAD AND DECIDED TO IMPLANT A BIVENTRICULAR DEFIBRILLATOR WITH THE INTENTION OF A FUTURE EPICARDIAL LEAD PLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R