BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2642623 · Received July 6, 2012

    Report

    Report Number
    3004209178-2012-05282
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Report Date
    June 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT # V900974, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT ADJUST HER STIMULATION. THE PATIENT STATED THAT SHE COULDN'T MAKE IT TO THE BATHROOM IN TIME. SHE DIDN'T FALL OR EXPERIENCE ANY TRAUMA ASSOCIATED WITH THE CHANGE IN THERAPY. THE PATIENT HAD DIABETIC NEUROPATHY, ARTHRITIS IN HER BACK AND LEGS FROM HIP DOWN AND ALSO HAS NEUROPATHY IN HER BLADDER, WHICH IS WHY SHE CAN'T HOLD HER URINE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS GETTING POOR COMMUNICATION WITH HER NEW PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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