BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3282316 · Received August 12, 2013

    Report

    Report Number
    3004209178-2013-14465
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Report Date
    July 17, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE DEVICE HAD BEEN TURNED OFF FOR YEARS. THE DEVICE HAD RECENTLY BEEN TURNED ON TO SEE IF IT WOULD WORK. A PATIENT PROGRAMMER WAS ORDERED FOR THE PATIENT, AS WELL AS AN ANTENNA. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HAVING PAIN. IT WAS FURTHER CLARIFIED BY THE HEALTHCARE PROFESSIONAL THAT THE PAIN WAS AT THE POCKET. THE PATIENT COULD HARDLY MOVE DUE TO THE PAIN, WHICH STARTED ABOUT 2 WEEKS PRIOR TO THE REPORT. OF NOTE, THE PATIENT HAD A FALL MONTHS AGO THAT AFFECTED THE ¿0 LEAD¿ BUT NO RECENT FALLS. THE STIMULATION HAD BEEN TURNED OFF SINCE THAT FALL. AFTER THE STIMULATION WAS TURNED BACK ON, THE PATIENT WAS OK FOR A WEEK IN TERMS OF PAIN, BUT WAS NOT GETTING ANY RESULTS. THE PATIENT HAD AN UPCOMING APPOINTMENT ON (B)(6) 2013. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385742 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR