BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3870555 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11513
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V564115, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S SYSTEM WAS REMOVED LAST YEAR BECAUSE THEY HAD 21 BLADDER INFECTIONS AND IT WAS UNCOMFORTABLE. THE PATIENT WAS IMPLANTED AND EXPLANTED WITH THEIR DEVICE AND WAS STILL HAVING BAD PROBLEMS FROM IT. IT WAS NOTED THAT THE PATIENT¿S BOWELS WERE COMING THROUGH THEIR VAGINA AND IT WAS ALL KIND OF A MESS. THE PATIENT MENTIONED HAVING TO TAKE ANTIBIOTICS AND ONLY SAW THE NURSE AS THEIR HEALTH CARE PROVIDER (HCP) DIDN¿T WANT TO SEE THEM. IT WAS REPORTED THAT THE LAST TIME THE PATIENT WAS AT HCP¿S OFFICE WAS 9 MONTHS AGO AND THEY GAVE THE PATIENT MORE ANTIBIOTICS AND THEY STOPPED TAKING THEM BECAUSE IT WAS NOT HELPING WITH THEIR URINARY TRACT INFECTION (UTI). IT WAS NOTED THAT THE PATIENT HAD A SLING IMPLANTED IN 2008 AND IT WAS JUST THERE AND THEIR HCP TOLD THE PATIENT THAT THEY DIDN¿T NEED TO COME SEE THEM ANYMORE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR HCP OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT TALKED TO SOMEONE ON (B)(6) 2014. IT WAS ALSO REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. THE PATIENT HAD TO CALL THE NUMBERS THAT WERE GIVEN TO THEM AND THEY WERE GIVEN QUITE A FEW NUMBERS TO CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347975 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention