BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3132677 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08219
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 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
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V350508, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DOING ¿GREAT,¿ BUT NEEDED AN MRI SO THE LEAD WAS REMOVED. UPON REMOVAL, THE LEAD BROKE AFTER THE FIRST TINE. A LATERAL IMAGE SHOWED THE ELECTRODE COLUMN STILL IN THE SACRUM. THE LEAD FRAGMENT WAS LESS THAN SIX CENTIMETERS LONG. TWO DAYS LATER, IT WAS INDICATED THE IMPLANTABLE NEUROSTIMULATOR WAS ALSO REMOVED AS OF THE DATE OF THIS REPORT. IT WAS STATED THE DEVICE ¿STOPPED WORKING.¿ IT WAS UNKNOWN WHY OR WHEN THE DEVICE STOPPED WORKING. AN X-RAY CONFIRMED THAT THERE WAS A FOUR MILLIMETER LEAD LEFT IN THE PATIENT¿S BODY. THE FOLLOWING DAY, IT WAS NOTED THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. THERE WAS NO SURGICAL INTERVENTION DONE REGARDING THE LEAD FRAGMENT IN THE PATIENT. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235465 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R