BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3666702 · Received March 7, 2014

    Report

    Report Number
    3004209178-2014-04047
    Event Type
    Injury
    Date Received
    March 7, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V132957, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN THROUGH TWO DIFFERENT BATCHES OF MEDICINE FOR INFECTION. IT WAS NOTED THE INFECTION WAS DUE TO THE IMPLANT. IT WAS REPORTED THE INFECTION STARTED TWO MONTHS PRIOR TO CALL. IT WAS REPORTED THE NIGHT PRIOR TO THE CALL THE PATIENT HAD ¿A CHILL¿ AND WAS SHAKING. IT WAS NOTED THE INFECTION WAS NOTICED IN A CULTURE, NOT IN THE PATIENT¿S URINE. IT WAS REPORTED THE PATIENT WAS ON ANTIBIOTICS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A SIMPLE URINARY TRACT INFECTION ON (B)(6) 2014. SIGNS AND SYMPTOMS OF INFECTION WAS DYSURIA. IT WAS NOTED THAT A CULTURE WAS OBTAINED AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139915 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention