BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3775366 · Received April 28, 2014

    Report

    Report Number
    3004209178-2014-08152
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    April 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V800436, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT HAD MOVED FROM LEFT TO RIGHT AND WAS CAUSING THE PATIENT A ¿GREAT DEAL¿ OF PAIN. THIS BEGAN TWO MONTHS PRIOR AND THE PATIENT WANTED THE DEVICE REMOVED. TWO DAYS LATER IT WAS ALSO NOTED THAT IT ¿NEVER WORKED¿ IN ADDITION TO CAUSING PAIN. THE PATIENT WANTED THE DEVICE REMOVED BECAUSE IT ¿NEVER HELPED HER.¿ IT WAS STATED THERE WERE NO SIDE EFFECTS, BUT THE PATIENT HAD BEEN IN BED IN PAIN EVER SINCE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255474 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1