BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3933228 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-13001
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 19, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3093-28, LOT# V762719, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECENTLY HAD PROBLEM WITH PAIN AND EXPERIENCING URINARY PROBLEMS AS WELL. THIS HAD BEEN GOING ON FOR SEVERAL WEEKS NOW. THE PATIENT NOTED IT WAS A SUDDEN CHANGE. THE PATIENT WAS WONDERING IF PROGRAMMER PROBLEMS COULD BE RELATED TO HER PAIN AND URINARY PROBLEMS. THE PATIENT NOTED SHE WAS GOING TO SEE A NEW DOCTOR TOMORROW, BUT WASN'T SURE IF THIS DOCTOR WILL BE MANAGING HCP (HEALTHCARE PROVIDER) OR NOT. THE PATIENT NOTED: "NOBODY IS MANAGING ME, NOBODY IS DOING ANYTHING, I'VE BEEN SO MIXED UP SINCE I HAD THE INTERSTIM AND I DON'T KNOW WHAT KIND OF MANAGEMENT I'M SUPPOSED TO BE RECEIVING." THE PATIENT STATED SHE HAD BEEN "LOST" WITH ALL OF THIS FOR 3 YEARS. THE PATIENT NOTED SHE HAD BEEN "LOST" WITH IF SHE WAS EVEN ON CORRECT SETTINGS OR NOT. THE PATIENT ASKED DOES THE DOCTOR DETERMINE EVERYTHING WITH THE SETTINGS WITH THE INTERSTIM. THE PATIENT ASKED CAN NURSES AT HCP OFFICE MAKE ADJUSTMENTS. THE PATIENT MENTIONED THAT A CERTAIN DOCTOR DID DO A "HUGE SURGERY" ON THE PATIENT IN (B)(6) 2011 AND DID A GOOD JOB. THE PATIENT WILL SEE THIS NEW DOCTOR TOMORROW. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409719 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR