BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3941363 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13168
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 25, 2014
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V295464, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVED A COUPLE OF MONTHS AFTER IMPLANT BECAUSE IT WAS PRESSING ON A NERVE. THE PATIENT HAD HAD ITCHING AND HIVES SINCE THE INS WAS MOVED. REGARDING WHETHER THE ONSET OF THE PROBLEM WAS SUDDEN OR GRADUAL, THE CALLER RESPONDED THAT IT HAPPENED "RATHER QUICKLY" AFTER THE IMPLANT WAS MOVED. THE CALLER REQUESTED ALLERGY TESTING MATERIALS. IT WAS REVIEWED THAT THERE ARE NO ALLERGY TESTING KITS FROM THE MANUFACTURER ANY LONGER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418252 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention