BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2834189 · Received November 15, 2012

    Report

    Report Number
    6000153-2012-00224
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A 'SLIGHT NICK' ON THE LEAD CASING, SPECIFICALLY THE RUBBER INSULATION AROUND THE WIRE OF THE LEAD. THE NICKED LEAD REPORTEDLY WAS REPLACED AND DISCARDED. IT WAS REPORTED THE NEXT DAY THAT THE PATIENT 'HAD THE EXACT SAME SENSATION' WITH THE NEW LEAD AND 'APPEARED TO BE DOING WELL.' IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3093-28 VA016U3

    Patients

    Seq Age Sex Outcome Treatment
    1