BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN ABILITY

    MDR report key: 2122387 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-10698
    Event Type
    Death
    Date Received
    June 13, 2011
    Date of Event
    March 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    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 INFORMATION HAS BEEN REQUESTED AND NOT YET RECIEVED. AS INFORMATION WILL BE SENT AS IT IS MADE AVAILABLE. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT INNER TUBING KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE.

    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 INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. AS INFORMATION WILL BE SENT AS IT IS MADE AVAILABLE. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. AS INFORMATION WILL BE SENT AS IT IS MADE AVAILABLE. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIAC DEFIBRILLATOR WAS RECEIVED FROM A HOSPITAL WITH INFORMATION THAT THE PATIENT HAD EXPIRED. LIMITED INFORMATION HAS BEEN MADE AVAILABLE REGARDING THE CIRCUMSTANCES OF THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE.

    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 74 YR Death| O LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD