BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4133299 · Received October 1, 2014

    Report

    Report Number
    3007566237-2014-02803
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE RECENTLY IMPLANTED PATIENT REPORTED THAT THERE WAS NO EDUCATION AT THE HOSPITAL ON HOW TO USE THE PROGRAMMER. THE PATIENT ALSO REPORTED THAT THEY HAD A TERRIBLE BLADDER INFECTION SINCE THE DAY PRIOR TO THIS CALL. THE PATIENT MET WITH THE HEALTH CARE PROVIDER ON THE DAY OF THIS CALL AND WAS PUT ON ANTIBIOTIC .THE PATIENT WAS ADVISED TO MAKE SURE THERAPY WAS ON AND IT WAS CONFIRMED THERAPY WAS SET ON PROGRAM 3 AT 1.60 V AND WAS ON. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610793 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention