BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3250917 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12382
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# VA08F3E, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED THAT THE IMPLANT SITE WAS HOT AND HARD. IT WAS NOTED THAT THE PATIENT WAS NOT RUNNING A FEVER. IT WAS FURTHER NOTED THAT THIS STARTED TWO DAYS PRIOR TO REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO A ¿(B)(6) INFECTION OF BATTERY POUCH.¿ IT WAS NOTED THAT THE DEVICE WAS EXPLANTED. IT FURTHER NOTED THAT THE IMPLANT WAS REMOVED ON 2013 (B)(6). IT WAS NOTED THAT HOSPITALIZATION WAS REQUIRED DUE TO THIS EVENT. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352503 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R