BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3231292 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11886
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA081HA, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PATIENT¿S PHYSICIAN STATED THE PATIENT HAD A ¿HISTORY OF UTIS.¿ REGARDING WHETHER THE UTIS WERE DUE TO A LEAD OR EXTENSION ISSUE, THE PHYSICIAN REPORTED IT WAS ¿DOUBTFUL.¿ IT WAS NOTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOKE UP WITH A URINARY TRACT INFECTION (UTI). THE PATIENT WAS PUT ON ANTIBIOTICS. THE PATIENT STATED THAT SHE WAS UNHAPPY BECAUSE SHE HAD GOTTEN THE DEVICE FOR THE UTI¿S. THE PATIENT WAS CONSIDERING HAVING THE IMPLANT REMOVED BECAUSE SHE WAS NOT HAPPY WITH THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332290 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention