BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3870349 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11506
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THAT THE SETSCREW WAS BACKED OUT TOO FAR AND CROSS THREADED. THE SETSCREW COULD NOT BE REALIGNED AND COULD NOT BE TIGHTENED DOWN ON TO A KNOWN GOOD LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT EVERYTHING WAS ¿OK¿ WITH THE NEW IMPLANTABLE NEUROSTIMULATOR THAT WAS PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SETSCREW OF THE IMPLANTABLE NEUROSTIMULATOR (INS) COULD ¿NOT BLOCK¿ THE LEAD.¿ IT WAS UNCLEAR WHAT THIS EXACTLY REFERRED TO. THE INS WAS NOT IMPLANTED AND A DIFFERENT INS WAS USED FOR THE PROCEDURE. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347230 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1