BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3874063 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11602
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 303, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-33, LOT# VA0E5GM, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL TODAY WITH A DIAGNOSIS OF INFECTION. IT WAS NOTED THAT THE PATIENT HAD TENDERNESS AND DRAINAGE FOR SEVERAL WEEKS. THE PATIENT WAS TO HAVE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED TODAY. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 CONFIRMED THAT THE PATIENT¿S DEVICE WAS EXPLANTED AND THAT THEY HAD GONE HOME. THE PATIENT REPORTEDLY DID FINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352688 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R