BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3223682 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11674
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3093-33, LOT# VA033KC, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS CAUSING PAIN BETWEEN THE PATIENT¿S ¿BUTT CRACK,¿ IN THE RECTUM, WHICH STARTED TWO WEEKS PRIOR TO THE REPORT. IT WAS DESCRIBED AS A SHOCKING SENSATION NEAR THE RECTUM. THE PATIENT REPORTEDLY TURNED STIMULATION OFF A FEW DAYS PRIOR TO THE REPORT TO GET RELIEF FROM THE PAIN. THE PATIENT ONLY FELT A DULL ACHE IN THAT AREA AT THE TIME OF THE REPORT. THE PATIENT WAS NOT AWARE OF ANY EVENT OR TRAUMA IN THE PAST TWO WEEKS THAT COULD HAVE BEEN CAUSING THE PAIN. FOR THE PAST TWO WEEKS, THE PATIENT HAD BEEN FEELING A DULL ACHE ON HER LEFT SIDE IN THE AREA OF HER KIDNEY. THE PATIENT FELT LETHARGIC AND SICK AND HER URINE HAD A BAD ODOR TO IT. THE PATIENT THOUGHT SHE MAY HAVE A BLADDER INFECTION AND REPORTEDLY HAD A HISTORY OF BLADDER INFECTIONS. THE PATIENT WAS HAVING A LOT OF DIFFICULTY SLEEPING AT NIGHT AND COULD NOT SLEEP ON THE LEFT SIDE BECAUSE OF THE PAIN. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT¿S FREQUENCY SYMPTOMS HAD RETURNED AND HAD BEEN HAVING A LOT OF ACCIDENTS, ESPECIALLY FIRST THING IN THE MORNING ¿IT JUST GUSHED OUT.¿ IT WAS NOTED THAT THE PATIENT WAS UP AT NIGHT A COUPLE OF TIMES. THE REPORTER INDICATED THAT THE PATIENT HAD ATTEMPTED TO CONTACT HER HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323014 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1