BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1830028 · Received September 10, 2010

    Report

    Report Number
    2649622-2010-08982
    Event Type
    Death
    Date Received
    September 10, 2010
    Date of Event
    June 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY(B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION MELTED. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SUDDEN CHANGE IN HIS HEALTH CONDITION AND WAS TAKEN TO THE EMERGENCY ROOM VIA AMBULANCE. HE WAS IN CARDIAC ARREST STATE AND "NOBODY COULD SPECIFY A CAUSE OF WHY THE PATIENT'S HEART STOPPED". THE PATIENT DIED ON (B)(6)-2010. AUTOPSY WAS PERFORMED, BUT RELEASE OF THE RESULTS WAS REFUSED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death