BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2533217 · Received April 12, 2012

    Report

    Report Number
    3004209178-2012-02338
    Event Type
    Injury
    Date Received
    April 12, 2012
    Report Date
    June 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL # 3889-28, LOT # V926977, IMPLANTED: 2012 (B)(6), EXPLANTED: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR CORRECTED FROM MANUFACTURING REPORT # 3004209178-2012-02338-1.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CONSTIPATION. THE PATIENT HAD BEEN EXPERIENCING, CRAMPING, CONSTIPATION AND DISCOMFORT SINCE IMPLANT. SUBSEQUENT REPORTING NOTED THAT THE PATIENT HAD ACUTE PAIN WITH LOWER LEFT ABDOMINAL PAIN. THE PATIENT WAS SEEN IN THE ER ON 2012 (B)(6) AND THE STIMULATION WAS TURNED OFF AND IMMEDIATELY THE PATIENT FELT BETTER. THE PATIENT SAW IMPLANTING HCP ON 2012 (B)(6) AND THEY SUGGESTED KEEPING STIM OFF UNTIL A COLONOSCOPY COULD BE DONE. THE ER INDICATED, THE PATIENT HAD COLITIS. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED ABDOMINAL CRAMPS AND GENERAL MALAISE WITH STIMULATION. A CT SCAN DID REVEAL COLITIS, INFLAMMATION OF THE COLON. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE EVENT WAS CAUSED BY UNDIAGNOSED CROHN'S DISEASE AND NOT BY THE DEVICE. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND DIARRHEA PRIOR TO THE EXPLANT, BUT HOSPITALIZATION WAS NOT REQUIRED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FECAL INCONTINENCE. IT WAS FURTHER NOTED THAT THE PHYSICIAN PERFORMED A CT SCAN AND FOUND THAT THE PATIENT HAD COLITIS, WHILE A SUBSEQUENT COLONOSCOPY REVEALED CROHN'S DISEASE. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED.

    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 Required Intervention