BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM II

    MDR report key: 3131905 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08303
    Event Type
    Death
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3093-28, LOT# V653973, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIED FROM HEART FAILURE, RESPIRATORY FAILURE, AND ASPIRATION PNEUMONIA. THE DEATH WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED. THE REPORTER STATED THAT THEY WERE NOT SURE WHAT THE CAUSE OF DEATH WAS. THE REPORTER STATED THAT THE HEALTH CARE PROVIDER (HCP) THOUGHT IT MAY HAVE BEEN ¿RENAL FAILURE DUE TO A URINARY TRACT INFECTION, HEART ATTACK, OR STROKE BUT ALL OF THE PATIENT¿S TESTS CAME BACK NORMAL.¿ IT WAS UNKNOWN IF THE DEATH WAS DEVICE RELATED OR NOT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235908 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death