BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2944304 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01323
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V931559, IMPLANTED: (B)(4) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE ANY CONCERNS WITH HER DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT 'STILL GOT INFECTIONS' AND HER DOCTOR TOLD HER 'THAT IT WOULD NOT.' IT WAS NOT CLEAR WHAT THAT MEANT. IT WAS STATED THAT THE PATIENT 'STILL LEAKS AND HAS TO WEAR A PAD.' IT WAS NOTED THAT HER DEVICE DID PROVIDE 'IMPROVEMENT' IN HER SYMPTOMS, BUT NOT COMPLETELY. ABOUT THREE WEEKS LATER IT WAS REPORTED FROM THE HEALTH CARE PROVIDER (HCP) THAT THE PATIENT WAS REFERRING TO URINARY TRACT INFECTIONS (UTI) AND THAT THERE WAS NO IMPLANT INFECTION. A CULTURE OF THE PATIENT'S URINE WAS OBTAINED AND THE TYPE OF ORGANISM CULTURED WAS E.COLI. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. IT WAS REPORTED THAT THE PATIENT'S INFECTION HAD RESOLVED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF UTIS BEFORE IMPLANTATION OF THE DEVICE. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49393 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention