BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2894294 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00079
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V548474, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 L OT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS HAVING AN UPCOMING POCKET REVISION SURGERY. THE REPORTER STATED THAT THE REASON FOR THE REVISION WAS THAT THE PATIENT LOST A LOT OF WEIGHT AND HER ANATOMY HAD CHANGED "AROUND THERE." TWO DAYS LATER, IT WAS REPORTED THAT THE POCKET REVISION WAS COMPLETED. IT WAS NOTED THAT THE PATIENT WAS HAPPY POST-OPERATIVELY. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DEVICE WAS MOVED THREE TIMES BECAUSE SHE WAS ¿OLD AND MY BUTT IS SAGGING¿ AND NOW ¿IT¿S ABOVE MY WAIST.¿ IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention