BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2403495 · Received January 8, 2012

    Report

    Report Number
    3004209178-2012-00137
    Event Type
    Malfunction
    Date Received
    January 8, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL # 3093-28, LOT # V151540, IMPLANTED 2008-(B)(6), EXPLANTED N/A; EXTENSION MODEL # 3095-10, LOT # NAH041456V, IMPLANTED 2008-(B)(6), EXPLANTED N/A; PROGRAMMER MODEL # 3037, LOT # NJD075896N.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNED OFF AND THE PATIENT HAD A RETURN OF SYMPTOMS. THE PATIENT HAD BEEN IN CLINIC AND HOSPITALS A LOT LATELY FOR HEART AND SLEEPING CONCERNS WHERE THERE MAY HAVE BEEN EXPOSURE TO EMI OR RADIATION FROM EQUIPMENT. THE STIMULATION WAS ABLE TO BE TURNED ON THE MORNING OF THE REPORT, BUT IT WAS UNCLEAR WHAT MIGHT HAVE CAUSED THE STIMULATION TO TURN OFF. THE PATIENT WILL BE HAVING HIP SURGERY ON 2012-(B)(6). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR