BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM

    MDR report key: 754935 · Received August 25, 2006

    Report

    Report Number
    3004209178-2006-01417
    Event Type
    Death
    Date Received
    August 25, 2006
    Date of Event
    August 10, 2006
    Report Date
    August 15, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    EZW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE MEDTRONIC INC HAS NOT RECEIVED THE DEVICE FOR EVALUTION. IF FURTHER NFORMATION IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT DIED IN 2006. THE HCP HAD NO FURTHER INFORMATION ON THE CAUSE OF DEATH. THE PATIENT'S HUSBAND REPORTED TO MEDTRONIC INC. THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE INTERSTIM NEUROSTIMULATOR SYSTEM. THE HCP HAD NO FURTHER INFORMATION ON THE CAUSE OF DEATH. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM IPG EZW MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death IMPLANTED| EXPLANTED| LEAD MODEL 3889 LOT# J0428260V