BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1230550 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07430
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    July 1, 2005
    Report Date
    October 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST HER STIMULATION. THE FUNCTIONING OF THE INTERSTIM DEVICE CHANGED WHEN SHE RECHARGED A NON-MEDTRONIC NEUROSTIMULATOR IN HER BACK. THE HEALTHCARE PROVIDER CONFIRMED THAT THE PATIENT'S INTERSTIM DEVICE HAD BEEN SHUTTING OFF SINCE THE PATIENT WAS IMPLANTED WITH A NON-MEDTRONIC NEUROSTIMULATOR IN HER BACK. THE PATIENT HAS HAD AN INCREASE IN URINARY FREQUENCY, NOCTURIA AND STRAINING TO VOID WAS INTERMITTENT. THE PATIENT WAS REPROGRAMMED. THE PATIENT HAD HER INTERSTIM DEVICE REPLACED. NO INJURIES TO THE PATIENT WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3080