BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3103393 · Received May 9, 2013

    Report

    Report Number
    6000153-2013-00092
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 22, 2013
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE LEAD FOUND NO ANOMALY. THE LEAD WAS ABLE TO PASS THROUGH A KNOWN GOOD CONDUCTOR WITHOUT ISSUE. (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 DURING IMPLANT OF THE LEAD, THE LEAD COULD NOT BE PULLED OUT OF THE LEAD INTRODUCER AND THERE DID NOT APPEAR TO BE A FRACTURE AT THE END OF ELECTRODE 0. ANOTHER LEAD INTRODUCER WAS USED WITH THE SAME RESULT. THE LEAD WAS TESTED AND DID NOT GET A GREAT RESULT, SO THEY TRIED TO MOVE THE LEAD. WHEN THEY TRIED TO REPOSITION THE LEAD AGAIN, IT WAS STILL CAUGHT. USE OF ANOTHER LEAD RESOLVED THE ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FINE AND RECEIVING EFFECTIVE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203846 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3889 VA078UW

    Patients

    Seq Age Sex Outcome Treatment
    1