BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2924616 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00804
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA04CLH, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BROKE OUT IN A RASH TWO DAYS AFTER THE IMPLANTING OF THE DEVICE. IT WAS STATED THE RASH STARTED AT THE IMPLANT SITE WHERE GLUE WAS USED. IT THEN SPREAD 'UP THE PATIENT'S BACK, DOWN THEIR LEGS AND INTO THEIR ARM.' THE INCISION SITE WAS DESCRIBED AS 'RAW.' BENADRYL AND CORTISONE CREAM WERE ADMINISTERED TO THE PATIENT. IT WAS NOTED THE PATIENT WAS ON A STEROID TREATMENT AND WAS TO FOLLOW UP WITH THEIR PERSONAL CARE PHYSICIAN TO ADDRESS THE RASH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE RASH WAS UNKNOWN. NO ABNORMAL IMPEDANCES WERE REPORTED. REPROGRAMMING WAS COMPLETED ON (B)(6) 2013. IT WAS NOTED THAT A FOLLOW-UP WAS PLANNED IN TWO WEEKS IN REGARDS TO THE REPROGRAMMING. NO HOSPITALIZATION AND NO INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30904 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention