BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY

    MDR report key: 6681628 · Received June 30, 2017

    Report

    Report Number
    3007566237-2017-02616
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 30, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889, PRODUCT TYPE: LEAD. 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.

    Description of Event or Problem · 1

    A TRIAL PATIENT REPORTED THE ISSUE IS HOLDING URINE SO HE DOESN'T DRIBBLE BECAUSE MAKING IT TO THE BATHROOM. ADDITIONAL INFORMATION FROM THE PATIENT ON (B)(6) REPORTED THEY WERE WORRIED ABOUT THE LEAD. THE PATIENT IS WORRIED HE WAS PULLING ON THE LEAD BECAUSE HE HAS MUSCULAR DYSTROPHY AND HAD TO SLIDE TO GET UP FROM THE BED. ADDITIONAL INFORMATION FROM THE PATIENT¿S SPOUSE ON (B)(6) REPORTED HE WAS CONFUSED ON HOW TO TRACK. THE PATIENT STATED SOMETIMES HE COULD NOT SIT DOWN FAST ENOUGH WHICH CAUSED HIM TO LEAK. ADDITIONAL INFORMATION FROM THE PATIENT ON (B)(6) REPORTED THE FIRST DAY HE HAD BLOOD FROM THE INCISION AREA. THE PATIENT ALSO STATED IT WAS A MESS BACK THERE AND THOUGHT ONE OF THE LEADS HAD BECOME LOOSE. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE INDICATION FOR USE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462263 VERIFY STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3531

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR