BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3092983 · Received May 3, 2013

    Report

    Report Number
    6000153-2013-00090
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE LEAD MODEL 3093-28 LOT VA04BGY FOUND NO ANOMALY. ANALYSIS OF THE STYLET FOUND NO SIGNIFICANT ANOMALY. THE STYLET WIRE WAS BENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_STYLET_ACC, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS CONCERNED THAT THE LEAD WAS NOT WORKING PROPERLY AND IT WAS NOT IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194755 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3093-28 VA04BGY

    Patients

    Seq Age Sex Outcome Treatment
    1