BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3382026 · Received October 2, 2013

    Report

    Report Number
    3004209178-2013-17346
    Event Type
    Injury
    Date Received
    October 2, 2013
    Report Date
    September 17, 2013
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V244043, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED BOWEL INCONTINENCE WHEN THE SYSTEM WAS MOVED TO THE OPPOSITE SIDE. WHEN THE REPRESENTATIVE MET WITH THE PATIENT, HER BATTERY WAS OFF AND SHE WAS HAVING FI (FECAL INCONTINENCE) AND UI (URINARY INCONTINENCE). THE DEVICE WAS TURNED BACK ON AND THE REPRESENTATIVE REPROGRAMMED HER BATTERY SO SHE FELT IT IN THE VAGINAL AREA. THE PATIENT'S BATTERY WAS LOW AND SHE WAS GETTING IT REPLACED. THE PATIENT WANTED THE SYSTEM PUT IN ON ITS ORIGINAL SIDE. ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED REVISION; PATIENT WANTED THE DEVICE PUT ON ITS ORIGINAL SIDE. REGARDING IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED, IT WAS NOTED YES: IMPEDANCE TESTING, X-RAYS, AND REPROGRAMMING. NORMAL BATTERY DEPLETION WAS NOTED. THE PATIENT NEVER HAD BOWEL PROBLEMS UNTIL SHE GOT HER INTERSTIM REIMPLANTED ON THE OPPOSITE SIDE DUE TO STIMULATION IN THE TAILBONE. THE PATIENT DIDN'T WANT IT MOVED TO THE OPPOSITE SIDE AND WHEN SHE WOKE UP IT WAS MOVED. SHE SAID THAT WAS WHEN HER BOWEL PROBLEMS STARTED. WHEN THE BATTERY WAS TURNED OFF SHE HAD BOWEL AND URINE PROBLEMS. THE REPRESENTATIVE MET WITH THE PATIENT TO ADJUST THE STIMULATION. THE REPRESENTATIVE WAS ABLE TO MOVE HER STIMULATION TO THE VAGINAL AREA AND DID AN IMPEDANCE TEST. HER BATTERY WAS VERY LOW AND NEEDED TO BE REPLACED. SHE WAS GETTING HER REPLACEMENT SCHEDULED AND WANTED IT PUT ON ITS ORIGINAL SIDE. PATIENT STATUS AT TIME OF THE REPORTING WAS NOTED AS ALIVE - NO INJURY. PATIENT SYMPTOMS NOTED WAS FI (FECAL INCONTINENCE). LOCATION OF SYMPTOM WAS THE RECTUM. THE PATIENT DEVELOPED FI WHEN SHE REVISED HER INTERSTIM. WHEN BATTERY WAS ON SHE DID WELL. WHEN IT WAS OFF FI (FECAL INCONTINENCE) COMES BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497803 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