BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SENSE

    MDR report key: 2213465 · Received August 16, 2011

    Report

    Report Number
    2649622-2011-13628
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    May 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    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 THE ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS RETURNED BY A COMPETITOR WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE EXPIRED. THE DATE OF DEATH WAS LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE, ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS REGARDING THE SYSTEM HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other