BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3190692 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10912
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 5, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3093-28 LOT# V010318, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR OR MEDTRONIC REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT'S BATTERY DIED AFTER "SIX PLUS" YEARS AND IT WAS GOING TO BE REPLACED.

    Description of Event or Problem · 1

    ABOUT A WEEK PRIOR TO THE DATE OF THIS REPORT, IT WAS STATED THAT EITHER ¿THE BATTERY WAS WORN OUT OR SOMETHING WAS GOING ON, IT WASN¿T WORKING LIKE IT WAS¿. THE REPORTER INDICATED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD REPORTEDLY BEEN ¿HAVING PROBLEMS, THE SAME PROBLEMS SHE HAD BEFORE IMPLANT¿. THE RETURN OF SYMPTOMS WAS INDICATED TO HAVE BEEN HAPPENING FOR ¿ABOUT THE LAST FEW MONTHS¿. THERE HAD HOWEVER NOT BEEN ANY PATIENT FALLS OR TRAUMA. AT THE TIME OF THE REPORT, THE ¿POOR COMMUNICATION SCREEN¿ WAS DISPLAYED WHEN AN ATTEMPT WAS MADE TO SYNCH WITH THE IMPLANTABLE NEUROSTIMULATOR. AS OF THE DATE OF THIS REPORT, IT WAS REPORTED THE PATIENT WENT TO THE HOSPITAL AND WAS THEN TOLD THAT THEY HAD A ¿MASSIVE¿ URINARY TRACT INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT'S "HAND METER WAS NOT ABLE TO READ" THE DEVICE. IT WAS NOTED THAT THE PATIENT'S DEVICE HAD SHUT OFF PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291609 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention