BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2402457 · Received January 6, 2012

    Report

    Report Number
    3004209178-2012-00115
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Report Date
    December 20, 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

    PROGRAMMER MODEL 3037 (B)(4), LEAD MODEL 3889-28 LOT# V052586 IMPLANTED: 2007-(B)(6) EXPLANTED: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND FELT THAT HER IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED TWO INCHES IN THE POCKET SITE. THE INS WOULD CATCH ON HER, FELT LOOSE, AND MOVED AROUND. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION ALL OVER HER BODY FOR ABOUT 20 MINUTES THAT SHE COULD NOT TURN OFF OR DOWN DUE TO POOR COMMUNICATION. THE PATIENT HAD NOT USED HER STIMULATOR FOR TWO YEARS BECAUSE SHE NO LONGER NEEDED IT, AND WANTED TO HAVE THE DEVICE REMOVED. THE PATIENT HAD AN APPOINTMENT WITH HER HCP SCHEDULED FOR (B)(6)-2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A CT SCAN ON 2012-(B)(6). THE HEALTH CARE PROFESSIONAL DETERMINED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS MOVING AROUND AND CAUSING INTESTINAL INFLAMMATION, AND RECOMMENDED DEVICE REMOVAL. IT WAS NOTED THAT THE PATIENT'S URINARY ISSUES HAD BEEN DUE TO DIABETES AND HAD DISAPPEARED WHEN THE PATIENT'S DIABETES WAS BROUGHT UNDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1