BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 6516791 · Received April 24, 2017

    Report

    Report Number
    3007566237-2017-01557
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 24, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A TRIAL PATIENT UNDERGOING A BASIC EVALUATION. IT WAS REPORTED THAT THE PATIENT WAS WAITING FOR THE IMPLANT DATE OF START (DOS) BECAUSE THE PATIENT NEEDED A CGC FIRST. IT WAS UNCLEAR WHAT WAS MEANT BY CGC. THE PATIENT HAD A UTI AND NEEDED TO TAKE ANTIBIOTICS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298978 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3057

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention