BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1882281 · Received October 26, 2010

    Report

    Report Number
    2649622-2010-11968
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    June 8, 2010
    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
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT ON (B)(6) 2010 THE DEVICE RECORDED OVERSENSING, MULTIPLE SHORT V-V SENSED EVENTS OF < 220 MS (SIX EPISODES OF NON-SUSTAINED TACHYCARDIAS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CLINIC RECEIVED A CARELINK TRANSMISSION REPORTING THE PATIENT HAD RECEIVED TWO SHOCKS ON (B)(6)-2010. IT WAS LATER REPORTED THE PATIENT HAD DIED ON (B)(6)-2010. THE PHYSICIAN "WONDERED" IF THERE WAS NOISE ON THE EGM. AFTER REVIEW OF THE EGM, THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT RECEIVED APPROPRIATE SHOCKS. BASED ON FOLLOW-UP WITH THE PHYSICIAN'S NURSE, THE PATIENT HAD BEEN "VERY SICK" AND WAS BEING FOLLOWED REGULARLY BY THE HEART FAILURE CLINIC, LAST SEEN THREE MONTHS PRIOR TO DEATH, AND WAS ON A TRANSPLANT LIST. THE DEATH CERTIFICATE LISTED THE IMMEDIATE CAUSE OF DEATH AS HEART FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    ASKU

    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 44 YR Death| L