BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4233240 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21107
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0GMM8, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT EVER SINCE THE PATIENT WAS IMPLANTED, "WHEN SHE GETS BY A MICROWAVE OVEN, IT HURTS HER, IT JARS HER. IF THEY TURN A MICROWAVE ON, IT SENDS SHARP SIGNALS TO HER AND IT HURTS. IT HAD BEEN LIKE THAT SINCE DAY ONE". 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.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE MANUFACTURER SYSTEM WAS NOT AFFECTED BY THE EMI AND WAS UNKNOWN IF THE DEVICE WAS ON POWER ON RESET (POR). IT WAS NOTED THAT PATIENT NEVER HAD THE COMPLAINT IN THE HEALTH CARE PROVIDER¿S OFFICE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT AND WAS HAPPY WITH THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712616 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR