BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM II

    MDR report key: 6088796 · Received November 9, 2016

    Report

    Report Number
    3004209178-2016-23481
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    October 24, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED (B)(4) NO LONGER APPLY TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURERS REPRESENTATIVE (REP) REPORTED THE PATIENT DEATH WAS NOT A DEVICE ISSUE. THE PHYSICIAN STATED IT WAS A CARDIAC ISSUE AND A PATIENT COMORBIDITY.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER'S REPRESENTATIVE (REP) THAT FOLLOWING IMPLANT THE CONSUMER DIDN'T COME OUT OF ANESTHESIA WELL, AND PASSED AWAY. IT WAS UNKNOWN WHAT CAUSED OR LED TO THIS, WHAT DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED, OR WHAT ACTIONS/INTERVENTIONS WERE TAKEN REGARDING THE EVENT. RELEVANT MEDICAL HISTORY INCLUDES URINARY DYSFUNCTION/SACRAL NERVE STIM. AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741863 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death