BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3122654 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07989
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    June 4, 2012
    Report Date
    March 21, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: REPORT SOURCES ADDED TO CORRECTLY REFLECT THE EVENT BEING PART OF A STUDY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT# V241707, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN SITTING. IT WAS STATED THE PATIENT FELT ¿SHOCKS¿ SINCE TURNING THE DEVICE ON AFTER AN ANKLE SURGERY IN EARLY (B)(6) 2012. THE DEVICE WAS TURNED OFF PRIOR TO THE SURGERY. IT WAS NOTED THE ETIOLOGY WAS PROGRAMMING. IMPEDANCES WERE MEASURED IN LATE (B)(6) 2012 AND THEY WERE ¿ALL FINE.¿ THE PATIENT WAS ALSO REPROGRAMMED AT THE SAME TIME. THE EVENT WAS STATED TO HAVE RESOLVED WITHOUT SEQUELAE IN LATE (B)(6) 2012. A FEW DAYS LATER, IT WAS INDICATED THAT THE SENSATION WAS DESCRIBED AS AN ELECTRIC SHOCK SENSATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224056 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR