BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY

    MDR report key: 4815647 · Received June 3, 2015

    Report

    Report Number
    3007566237-2015-01540
    Event Type
    Injury
    Date Received
    June 3, 2015
    Report Date
    May 17, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3537, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CALLER WAS IN STAGE 1 AND SCHEDULED FOR STAGE 2 THREE DAYS FROM THE DAY OF REPORT. THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SHE HAD BLADDER RETENTION WITH THE INITIAL PROGRAM AND WAS NOT VOIDING, SO THEY WERE CHANGED TO ANOTHER PROGRAM. IT WAS INDICATED "A LADY" WALKED THE PATIENT THROUGH CHANGING PROGRAMS AGAIN TWO DAYS PRIOR TO REPORT BECAUSE THE PROGRAM WASN'T "WORKING" AND SHE WAS ONLY GOING A "TRICKLE." PRIOR TO CHANGING THE PROGRAM TWO DAYS PRIOR, THE PATIENT WAS DOING REALLY WELL, "100, 125, 200, 100." THE PATIENT WAS BACK TO "NOTHING" AGAIN. IT WAS NOTED THE PATIENT WANTED TO GET BACK TO THE MIDDLE PROGRAM, BUT WAS NOT SURE IF IT WAS PROGRAM 1 OR 3. THE NIGHT PRIOR, "A MAN" REPRESENTATIVE CALLED THE PATIENT, BUT SHE HAD NO KNOWLEDGE OF THE NAMES OF ANY OF THE REPRESENTATIVES SHE HAD SPOKEN TO PREVIOUSLY. NO OUTCOME WAS PROVIDED REGARDING THIS EVENT, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358486 VERIFY STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other