BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3942919 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13206
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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# V744243, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NEVER HAVING THERAPEUTIC EFFECT. THE PATIENT STATED THAT SHE "IS NOT SURE IF ITS DOING ANY GOOD FOR ME SINCE THE IMPLANT, IT HASN'T REALLY HELPED. THE REPRESENTATIVE TOLD ME I WOULD HAVE MY LIFE BACK BUT I DON'T HAVE IT BACK. I STILL HAVE TO GO TO THE BATHROOM A LOT AND I THOUGHT IT WOULD HAVE HELPED THAT". THE PATIENT GOES TO GET AN ADJUSTMENT TO HER DEVICE EVERY 3-4 MONTHS BUT SAYS SO FAR IT HASN'T HELPED ANY. THE PATIENT ASKED HOW SHE WOULD KNOW IF ITS HELPING. INFECTION WAS NOTED. THE PATIENT NOTED SHE HAS "INFECTIONS ALL OVER THE PLACE". AND THEN CLARIFIED THAT SHE HAS "BLADDER INFECTIONS CONSTANTLY AT LEAST SINCE I'VE HAD THE {COMPANY NAME} BUT PROBABLY FOR ABOUT 5 YEARS". THE PATIENT ASKED IF SHE MIGHT WANT THE DEVICE TAKEN OUT BECAUSE ITS NOT HELPING, HOW THAT WORKS. THE PATIENT STATED THAT SHE KNOWS THAT SHE CAN'T HAVE AN MRI WITH THE STIMULATOR IMPLANTED. THE PATIENT ASKED IF THE DEVICE WOULD LAST 5 YEARS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419009 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other