BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4276742 · Received November 25, 2014

    Report

    Report Number
    3004209178-2014-22169
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Report Date
    November 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V072754, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-33, LOT# V072754, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS WITH HER MOTHER FOR AN APPOINTMENT ON THE DAY OF THIS CALL AND HER MOTHER WAS HAVING SOMETHING CAUTERIZED ON HER NOSE. THE PATIENT STATED SHE WAS HOLDING HER MOTHER¿S HAND AND SHE FELT A SHOCKING OR JOLTING SENSATION GO DOWN HER LEG DURING THE PROCEDURE. THE PATIENT STEPPED AWAY AS SOON AS SHE FELT THE SENSATION BUT WANTED TO KNOW IF THERE COULD BE ANY DAMAGE INTERNALLY. THE PATIENT ALSO MENTIONED SHE HAD NOT HAD THE THERAPY FOR THE PAST 2 YEARS "BECAUSE SHE HAD NOT NEEDED IT. THE PATIENT INDICATED THAT SHE WAS NOT FEELING ANY PAIN. 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
    763325 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR