BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN ABILITY

    MDR report key: 2230035 · Received August 31, 2011

    Report

    Report Number
    2649622-2011-13750
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    December 24, 2010
    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
    MN, US
    Reporter Occupation
    OTHER

    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): THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    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) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS ARE STRETCHED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS ARE STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS ARE STRETCHED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS RETURNED WITH NO INFORMATION. A SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE EXPIRED. THE PATIENT HAD EXPIRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP THAT WAS DONE REVEALED THE CAUSE OF DEATH TO BE A CARDIAC ARREST. NO FURTHER INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THE DEATH HAVE BEEN MADE AVAILABLE THROUGH FOLLOW UP AND ALL LEADS HAVE BEEN EXHAUSTED.

    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 68 YR Death| O