BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2152313 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04706
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE DEVICE HAD STOPPED BY ITSELF. THE PATIENT WAS UNABLE TO SYNC THE DEVICE WITH THE PATIENT PROGRAMMER. PRE-IMPLANT SYMPTOMS RETURNED. WHEN THE PATIENT WAS SEEN BY THE MANUFACTURER'S REPRESENTATIVE, THE REPRESENTATIVE WAS ALSO UNABLE AFTER MULTIPLE ATTEMPTS TO GET THE PATIENT PROGRAMMER TO DETECT THE INS. THE REPRESENTATIVE RESET THE PATIENT'S REMOTE AND IT WORKED. ONCE THE PATIENT WAS HOME, THE DEVICE AGAIN STOPPED WORKING. THE PATIENT TRIED THE PROGRAMMER AND AGAIN IT WAS UNABLE TO SYNC WITH THE INS. PATIENT HAS DEVELOPED ISSUES WITH HER L1 NERVE IN HER HIP SINCE DEVICE IMPLANT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

    Seq Age Sex Outcome Treatment
    1