BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3153237 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08899
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    June 2, 2011
    Report Date
    January 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V598061, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INCREASE IN URINARY TRACT INFECTIONS, WHICH WAS NOTED AS A WORSENING OR EXACERBATION OF A PRE-EXISTING CONDITION. THE PATIENT SYMPTOMS WERE NOTED AS INCREASED FREQUENCY OF URINATION AND BURNING. INTERVENTION INCLUDED MACROBID, CIPRO AND ABX, WHICH WAS PRESCRIBED BY EXTERNAL PROVIDER, UNKNOWN DRUG/DOSE. THE PATIENT OUTCOME WAS NOTED AS ONGOING EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED LAB FOUR MONTHS AGO WAS NEGATIVE FOR UTI, THE PATIENT CONTINUED WITH SUBJECTIVE SENSE OF UTI, AND WAS STARTED ON AMOXICILLIN TWO MONTHS AGO. THE PATIENT COMPLAINED OF DYSURIA AND STARTED KEFLEX TWO MONTHS AGO ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256067 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention