BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3020696 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04218
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V260802, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# V535669, IMPLANTED: (B)(6) 2010, 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 HAD EXPERIENCED 'DISCOMFORT AND SORENESS IN THE POCKET AREA' SINCE (B)(6) 2012. IT WAS NOTED THAT THE PATIENT HAD RECEIVED 'VERY GOOD SYMPTOM RELIEF.' IT WAS FURTHER REPORTED THAT THE PATIENT HAD A POCKET REVISION PERFORMED TO MOVE THE DEVICE TO A DIFFERENT LOCATION. IT WAS NOTED THAT 'THE PHYSICIAN WAS ABLE TO PERFORM THE REVISION WITHOUT DETACHING THE DEVICE FROM THE LEAD.' IT WAS STATED THAT THE PATIENT WAS 'DOING WELL' AND THAT THE PATIENT 'NO LONGER EXPERIENCED ANY DISCOMFORT AT THE POCKET SITE.' A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123760 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention