BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3121823 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07962
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    December 10, 2012
    Report Date
    May 1, 2013
    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

    PRODUCT ID: 3889-28, LOT# V571447, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION (UTI). THE PATIENT WAS TREATED WITH MACROBID (100 MG BID X 7 DAYS. THE PATIENT OUTCOME WAS REPORTED AS AN ON-GOING EVENT IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME OF THE EVENT, AS NOTED ON (B)(6) 2013, WAS RESOLVED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT ACTUALLY RESOLVED WITHOUT SEQUELA ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223533 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention