BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4213653 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20653
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V318392, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCED BLADDER INFECTION THAT STARTED TO BOTHER HER IN END OF (B)(6) 2014. THE PATIENT STATED IT GOT REALLY BAD AGAIN RECENTLY AND HEALTH CARE PROVIDER INFORMED PATIENT THAT SHE WAS VERY RED ON THE INSIDE. THE PATIENT WAS ON ANTIBIOTICS AND SHE WAS IN BED FOR A FEW DAYS. THE PATIENT STATED IT HAS BEEN YEARS SINCE SHE USED THE INTERSTIM IMPLANT, SHE JUST FORGOT ABOUT IT AND DIDN'T REALIZE THAT HER NEUROSTIMULATOR HAD A BATTERY THAT WOULD RUN OUT. THE PATIENT HAD NOT CHECKED HER NEUROSTIMULATOR BUT WOULD MAKE AN APPOINTMENT TO GET IT CHECKED WITH THE HEALTH CARE PROVIDER. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695794 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention