BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2538496 · Received April 17, 2012

    Report

    Report Number
    3004209178-2012-02421
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Report Date
    March 23, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL: 3093-28, LOT#: V030176, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. PROGRAMMER MODEL: 3037, SERIAL#: (B)(4). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2012 THAT INDICATED THAT THE MANUFACTURER REPRESENTATIVE LOCATED A REPLACEMENT PROGRAMMER FOR THE PATIENT, REPROGRAMMED HER STIMULATOR AND BONDED THE STIMULATOR TO THE NEW PATIENT PROGRAMMER. HE STATED THAT THE PATIENT LEFT THE OFFICE HAPPY WITH PERFECT VAGINAL SENSATION, WITHOUT SHOCKING. THIS ALL HAPPENED WEEKS AGO, AND HE HAD NOT HEARD THAT ANYTHING HAD CHANGED SINCE THE REPROGRAMMING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION FOLLOWING EXPOSURE TO A THEFT DETECTOR AT (B)(6) AND AT OTHER STORES WHEN THE DEVICE WAS TURNED ON. THE PATIENT ALSO REPORTED A LOSS OF THERAPEUTIC EFFECT AND THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND STATED THAT IT WAS NOT WORKING FOR HER. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT LOST HER PROGRAMMER AND COULD NOT ADJUST THE SETTINGS OF HER INS. IT WAS ALSO NOTED THAT THE PATIENT MAY HAVE FALLEN CAUSING DAMAGE TO THE INS OR LEAD MIGRATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1