BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3202813 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11230
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-28, LOT# VA098A6, IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCISION TO THE PATIENT¿S POCKET SITE GOT INFECTED. THE PATIENT HAD A STAPLE AT THE ¿LITTLE CUT¿ AND 1 STITCH ON THE BOTTOM OF THE INCISION THAT NEEDED TO BE TAKEN OUT. THIS WAS REPORTEDLY DONE. HOWEVER THE PATIENT¿S HEALTHCARE PROVIDER (HCP) NEVER ¿LOOKED AT IT¿. WHEN THE TAPE CAME OFF, THE PATIENT SAW SOME DRAINAGE THAT WAS ¿YELLOW, GREEN AND GOOPY¿. THE PATIENT COULD TELL ¿IT WAS OPEN¿. THE NURSE REPORTEDLY ¿CLEANED IT UP¿ AND ¿COVERED IT¿. THE HCP LOOKED AT IT AFTERWARDS AND THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC TO TAKE FOR THE INFECTION SINCE SHE WAS GETTING SORE. THE REPORTER INDICATED THAT THERE WAS STILL SEEPAGE, BUT IT WAS BETTER. IT STILL LOOKED ¿GROSS¿ COMPARED TO THE REST OF THE STITCHING. IT WAS STILL DRAININGAT THE TIME OF THE REPORT. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURER'S REPRESENTATIVE OR HEALTHCARE PROVIDER AND HER CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302466 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention