BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3133722 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08251
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 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 3093-28, LOT# V691380, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ¿FOUL SMELLING URINE¿ AND ABNORMAL FINDINGS ON URINALYSIS. THE PATIENT HAD A URINARY TRACT INFECTION (UTI) AND WAS TREATED WITH ¿KEFLEX.¿ THE OUTCOME WAS NOTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236372 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention