BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2822878 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-10002
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V394067, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A URINARY TRACT INFECTION (UTI). IT WAS STATED THAT THE PATIENT HAD A UTI AND THAT IT HAD "NOTHING TO DO WITH STIMULATION." NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "EXPERIENCING NUMEROUS" BLADDER INFECTIONS. ANTI-BIOTICS WERE USED AND INTRAVENOUS ANTI-BIOTICS MAY HAVE BEEN USED IF THE ORIGINAL MEDICATION WAS UNSUCCESSFUL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention