BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4135972 · Received October 2, 2014

    Report

    Report Number
    3004209178-2014-18183
    Event Type
    Injury
    Date Received
    October 2, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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# V926162, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PROBLEMS WITH THEIR BLADDER. THE PATIENT EXPERIENCED BLADDER INFECTIONS AND THEY HAD GOTTEN WORSE OVER THE YEAR. THE INFECTIONS STARTED A MONTH OR TWO AFTER THEY CLEARED UP. THE PATIENT GOT AN INFECTION TWO WEEKS AFTER BEING ON ANTIBIOTICS FOR FOUR WEEKS. THE PATIENT EXPERIENCED FREQUENCY WHILE THEY HAD AN INFECTION. THE PATIENT GOT UP SEVEN TIMES FOUR OR FIVE NIGHTS AGO. THE PATIENT¿S CURRENT INFECTION WAS CAUSING HIGH BLOOD PRESSURE. THE PATIENT RECENTLY HAD A ¿LITTLE STROKE.¿ NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616578 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention