BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4027917 · Received August 21, 2014

    Report

    Report Number
    3004209178-2014-15708
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    July 28, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V896640, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PATIENT RECEIVED ASSISTANCE FROM THEIR MANUFACTURER REPRESENTATIVE AND HEALTHCARE PROVIDER AND HER CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS INDICATED THAT PATIENT GOT TELEMETRY ERROR AND SHE REPLACED THE BATTERIES. THE PATIENT REINSTALLS THEM AGAIN, SINCE PROGRAMMER (PP) DIDN'T TURN ON. IT WAS INDICATED THAT IT WORKED WITH AND WITHOUT ANTENNA. IT WAS INDICATED THAT THE PATIENT TRIED TO CHECK HER IMPLANT THE OTHER DAY AND SHE WASN'T ABLE TO DO IT. THE PATIENT REPORTED THAT THE SYMPTOM REPORTED HAD A SUDDEN ONSET. THE PATIENT FELT SHE WAS GOING MORE OFTEN AND IT HAD BEEN A WEEK. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504779 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1