BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 2083630 · Received May 10, 2011

    Report

    Report Number
    2649622-2011-07475
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    March 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CALL TO TECHNICAL SERVICES CAME IN ON (B)(6) 2011 TO REPORT NOT SEEING VENTRICULAR CAPTURE. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA BIMONTHLY MED WATCH REPORT SUBMISSION THAT WOULD HAVE BEEN SUBMITTED ON (B)(6) 2010. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH THIS EVENT NO LONGER QUALIFIES FOR THE BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE ELECTROGRAM VENTRICULAR CAPTURE WAS UNABLE TO BE SEEN. ADDITIONAL INFORMATION OBTAINED REVEALED THE PATIENT DIED TWO DAYS AFTER THE EPISODE. THE LAST CLINIC VISIT WAS FOUR DAYS PRIOR TO THE EPISODE AND THE DEVICE WAS INTERROGATED SHOWING NORMAL FUNCTION AND HAD AN EXPECTED BATTERY LIFE OF FIVE TO SEVEN YEARS. CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death