BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2131365 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10478
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A CORRECTION HAS BEEN MADE ON THE DEVICE PUD202711H AND THE LEAD LFG049937V. THE RECALL CODE HAS BEEN REMOVED AS THERE IS NO REMEDIAL ACTION CODE FOR THESE PRODUCTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT (B)(4) BACTEREMIA AND SEPSIS AND VEGETATIONS WERE VISUALIZED ON THE LEADS WHICH LEAD TO THE EXTRACTION OF THE ENTIRE SYSTEM PLUS AN ABANDONED RV LEAD. ADDITIONALLY, AFTER EXTUBATION POST PROCEDURE, THE PATIENT FAILED TO BREATHE SPONTANEOUSLY AND REQUIRED RE-INTUBATION, THE PATIENT HAD A HEMATOMA AT THE DEVICE EXTRACTION SITE WHICH REQUIRED SURGICAL INTERVENTION, AFTER THE POCKET EVACUATION THE PATIENT HAD A CARDIAC ARREST AND HAD PULSELESS ELECTRICAL ACTIVITY FOR A FEW MINUTES, BUT RECOVERED AFTER ONE ROUND OF MEDICATION, AND THE PATIENT'S RIGHT UPPER ARM HAD SWELLING. THE SYSTEM WAS NOT REPLACED. IT WAS LATER DETERMINED THAT THE LEFT VENTRICULAR LEAD WAS FOUND TO HAVE BEEN IMPLANTED AFTER THE USE BY DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW AND DUE TO CORRECTION OF THE SERIAL NUMBER, IT WAS DETERMINED THAT THE LV (LEFT VENTRICULAR) LEAD WAS NOT IMPLANTED AFTER THE UBD (USE BY DATE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT (B)(6) AND SEPSIS AND VEGETATIONS WERE VISUALIZED ON THE LEADS WHICH LEAD TO THE EXTRACTION OF THE ENTIRE SYSTEM PLUS AN ABANDONED RV LEAD. ADDITIONALLY, AFTER EXTUBATION POST PROCEDURE, THE PATIENT FAILED TO BREATHE SPONTANEOUSLY AND REQUIRED RE-INTUBATION, THE PATIENT HAD A HEMATOMA AT THE DEVICE EXTRACTION SITE WHICH REQUIRED SURGICAL INTERVENTION, AFTER THE POCKET EVACUATION THE PATIENT HAD A CARDIAC ARREST AND HAD PULSELESS ELECTRICAL ACTIVITY FOR A FEW MINUTES BUT RECOVERED AFTER ONE ROUND OF MEDICATION, AND THE PATIENT'S RIGHT UPPER ARM HAD SWELLING. THE SYSTEM WAS NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTB MEDTRONIC PUERTO RICO, INC. 419488 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R