BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3250094 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12359
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 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
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# VA006YW, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. IT WAS NOTED THAT THE PATIENT MAY HAVE HAD A URINARY TRACT INFECTION OR A BLADDER INFECTION. A CULTURE WAS TAKEN 2013 (B)(6). THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT IT DID NOT SEEM LIKE THE IMPLANT WAS WORKING AT ALL. IT WAS FURTHER NOTED THAT WHEN THEY ¿TURNED IT ON IT WOULD SAY THAT IT WAS NOT ON.¿ STIMULATION WAS AT 4.0 BUT WAS DECREASED TO 3.7. PATIENT WAS EXPERIENCING DISCOMFORT AND ACUTE PAIN. STIMULATION WAS DECREASED TO 3.5 AND WAS A MORE COMFORTABLE SETTING FOR THE PATIENT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM DOCTOR¿S OFFICE NOTED NO DIAGNOSTICS HAD BEEN PERFORMED ON THE DEVICE. THE PATIENT EXPERIENCED 2 BLADDER INFECTIONS, ONE ON (B)(6) 2013 AND ONE ON (B)(6) 2013. THE BLADDER INFECTIONS WERE NOT CONSIDERED TO BE RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BLADDER INFECTION 3 WEEKS AFTER IMPLANT AND HAD IT 7 TIMES SINCE IMPLANT. TIMES THEY TURNED OFF THE INS AND IT HAD BEEN OFF FOR MONTHS. WHEN THE PATIENT LEFT THE HOSPITAL THE INS WAS WORKING. THEY CHANGED TO PROGRAM 1 AT 4.3 AND CHANGED TO PROGRAM 2 AT 3.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350443 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention